The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Period of Hypophysectomy

September 22, 2022 updated by: Feng Gao, Tongji Hospital

The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study

The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can provide stable hemodynamics and reduce the hemodynamic fluctuation the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Surgical stimulation is one of the important factors leading to hemodynamic fluctuation and affecting postoperative recovery quality. The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain because of there were numerous nerve endings at the surgical site which is originated from branches of the trigeminal nerve (including infraorbital and infratrochlear nerve). It's difficult to suppress intraoperative stimulation at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. It's reported that pterygomaxillary fossa block can inhibit hypertension caused by surgical procedures, however the block may cause complications because of its complicated operations. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can reduce the pain in the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear. Therefore, the investigators propose the hypothesis that preoperative bilateral infraorbital and infratrochlear nerve block could effectively reduce the pain in patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary. The objective of this study is to observe the heart rate and blood pressure at a specific point in time during the operation and pain at 2, 8, 24, 48 hours postoperatively between adult patients receiving or not receiving bilateral infraorbital and infratrochlear nerve block.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Elective endoscopic binostril transnasal transsphenoidal resection
  • 2. Patients aged between 18 and 65.
  • 3. American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III

Exclusion Criteria:

  • 1. Emergency operation.
  • 2. Patients allergic to ropivacaine.
  • 3. Infection nearby the puncture point.
  • 4. Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
  • 5. Patient with renal insufficiency or hepatic failure.
  • 6. Patients who have undergone craniotomy in the recent 6 months.
  • 7. Pregnant or lactating women, being participating in other studies.
  • 8. Patients unable to cooperate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Nerve Block Group
Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. Infraorbital nerve block was performed while using an extraoral approach. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 mL of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.
Drug: nerve block with 0.5% ropivacaine
After general anesthesia, the patients will receive bilateral infraorbital and infratrochlear nerve block 30 minutes prior to surgery. Infraorbital nerve block is performed while using an extraoral approach. A 25-gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 ml of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed infratrochlear nerve block. After negative aspiration of blood, 1 ml of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.
SHAM_COMPARATOR: Control Group
Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
Other: without any nerve block
Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
Other Names:
  • nerve block with 0.5% ropivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MAP within 10 minutes after nerve block
Time Frame: within 10 minutes after nerve block
MAP within 10 minutes after nerve block
within 10 minutes after nerve block
HR within 10 minutes after nerve block
Time Frame: within 10 minutes after nerve block
HR within 10 minutes after nerve block
within 10 minutes after nerve block
mean arterial pressure (MAP) before nerve block
Time Frame: before nerve block
mean arterial pressure (MAP) before nerve block
before nerve block
heat rate (HR) before nerve block
Time Frame: before nerve block
heat rate (HR) before nerve block
before nerve block
MAP before nasal mucosal dissection
Time Frame: before nasal mucosal dissection
MAP before nasal mucosal dissection
before nasal mucosal dissection
HR before nasal mucosal dissection
Time Frame: before nasal mucosal dissection
HR before nasal mucosal dissection
before nasal mucosal dissection
MAP immediately after nasal mucosal dissection
Time Frame: immediately after nasal mucosal dissection
MAP immediately after nasal mucosal dissection
immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
Time Frame: immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
immediately after nasal mucosal dissection
MAP before septum resection
Time Frame: before septum resection
MAP before septum resection
before septum resection
HR before septum resection
Time Frame: before septum resection
HR before septum resection
before septum resection
MAP immediately after septum resection
Time Frame: immediately after septum resection
MAP immediately after septum resection
immediately after septum resection
HR immediately after septum resection
Time Frame: immediately after septum resection
HR immediately after septum resection
immediately after septum resection
MAP before sella bone resection
Time Frame: before sella bone resection
MAP before sella bone resection
before sella bone resection
HR before sella bone resection
Time Frame: before sella bone resection
HR before sella bone resection
before sella bone resection
MAP after sella bone resection
Time Frame: before sella bone resection
MAP after sella bone resection
before sella bone resection
HR immediately after sella bone resection
Time Frame: immediately after sella bone resection
HR immediately after sella bone resection
immediately after sella bone resection
MAP before dural incision of sella
Time Frame: before dural incision of sella
MAP before dural incision of sella
before dural incision of sella
HR before dural incision of sella
Time Frame: before dural incision of sella
HR before dural incision of sella
before dural incision of sella
MAP immediately after dural incision of sella
Time Frame: immediately after dural incision of sella
MAP immediately after dural incision of sella
immediately after dural incision of sella
HR immediately after dural incision of sella
Time Frame: immediately after dural incision of sella
HR immediately after dural incision of sella
immediately after dural incision of sella
MAP before exploration of pituitary fossa
Time Frame: before exploration of pituitary fossa
MAP before exploration of pituitary fossa
before exploration of pituitary fossa
HR before exploration of pituitary fossa
Time Frame: before exploration of pituitary fossa
HR before exploration of pituitary fossa
before exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
Time Frame: immediately after exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
Time Frame: immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
immediately after exploration of pituitary fossa

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)
Time Frame: when patient enters PACU (immediately after surgery)
numerical rating scale (NRS) score when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
when patient enters PACU (immediately after surgery)
numerical rating scale (NRS) score before patient leaves PACU
Time Frame: before patient leaves PACU
numerical rating scale (NRS) score before patient leaves PACU. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
before patient leaves PACU
NRS 2 hours after surgery
Time Frame: 2 hours after surgery
NRS 2 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
2 hours after surgery
NRS 8 hours after surgery
Time Frame: 8 hours after surgery
NRS 8 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
8 hours after surgery
NRS 24 hours after surgery
Time Frame: 24 hours after surgery
NRS 24 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
24 hours after surgery
NRS 48 hours after surgery
Time Frame: 48 hours after surgery
NRS 48 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
48 hours after surgery
quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery
Time Frame: 1 day after surgery
quality of recovery Scale (QoR-15): QoR-15 1 day after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
1 day after surgery
quality of recovery Scale: QoR-15 3 days after surgery
Time Frame: 3 days after surgery
quality of recovery Scale: QoR-15 3 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
3 days after surgery
quality of recovery Scale: QoR-15 7 days after surgery
Time Frame: 7 days after surgery
quality of recovery Scale: QoR-15 7 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality.
7 days after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
incidence of postoperative nausea and vomiting (PONV) within 24 hours
Time Frame: within 24h after surgery
within 24 hours after surgery, the investigators record the number of patients who suffer from PONV, and then calculate the incidence as: the number of patient suffering from PONV/the total number in corresponding group
within 24h after surgery
incidence of postoperative nausea and vomiting (PONV) within 48 hours
Time Frame: within 48 hours after surgery
within 48 hours after surgery, the investigators record the number of patients who suffer from PONV, and then calculate the incidence as: the number of patient suffering from PONV/the total number in corresponding group
within 48 hours after surgery
Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery)
Time Frame: when patient enters PACU (immediately after surgery)
Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
when patient enters PACU (immediately after surgery)
Ramsay sedation scale (RSS) before patient leaves PACU
Time Frame: before patient leaves PACU
Ramsay sedation scale (RSS) before patient leaves PACU. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
before patient leaves PACU
Ramsay sedation scale (RSS) 2 hours after surgery
Time Frame: 2 hours after surgery
Ramsay sedation scale (RSS) 2 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
2 hours after surgery
Ramsay sedation scale (RSS) 8 hours after surgery
Time Frame: 8 hours after surgery
Ramsay sedation scale (RSS) 8 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
8 hours after surgery
Ramsay sedation scale (RSS) 24 hours after surgery
Time Frame: 24 hours after surgery
Ramsay sedation scale (RSS) 24 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
24 hours after surgery
Ramsay sedation scale (RSS) 48 hours after surgery
Time Frame: 48 hours after surgery
Ramsay sedation scale (RSS) 48 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation).
48 hours after surgery
operation time
Time Frame: from the time of surgery beginning until end time of surgery
from the time of surgery beginning until end time of surgery
from the time of surgery beginning until end time of surgery
anesthesia time
Time Frame: from the time of anesthesia beginning until end time of anesthesia
from the time of anesthesia beginning until end time of anesthesia
from the time of anesthesia beginning until end time of anesthesia
awakening time
Time Frame: from the time of anesthesia end until the time of patient awaken
from the time of anesthesia end until the time of patient awaken
from the time of anesthesia end until the time of patient awaken
PACU staying time
Time Frame: from the time of patient coming in PACU until the time of patient coming out PACU
time from the time of patient coming in PACU until the time of patient coming out PACU
from the time of patient coming in PACU until the time of patient coming out PACU
anesthetic dosage
Time Frame: during surgery
use dosage of anesthetic drug during operation
during surgery
urine volume
Time Frame: during surgery
urine volume during surgery
during surgery
bleeding volume
Time Frame: during surgery
bleeding volume during surgery
during surgery
maintenance infusion rate of remifentanil
Time Frame: during surgery
infusion rate of remifentanil for maintaining effective analgesic effect during surgery
during surgery
the dosage of remedial painkillers (remifentanil)
Time Frame: during surgery
the dosage of remedial painkillers (remifentanil) during surgery
during surgery
the dosage of remedial perdipine
Time Frame: during surgery
the dosage of remedial perdipine during surgery
during surgery
the dosage of remedial esmolol
Time Frame: during surgery
the dosage of remedial esmolol during surgery
during surgery
the time of initial administration of remedial antiemetics within 48 hours
Time Frame: within 48 hours after surgery
the time of initial administration of remedial antiemetics within 48 hours after surgery
within 48 hours after surgery
the dosage of remedial antiemetics within 48 hours
Time Frame: within 48 hours after surgery
the dosage of remedial antiemetics within 48 hours after surgery
within 48 hours after surgery
incidence of hematoma at the block point in both two groups within 24 hours
Time Frame: within 24 hours after surgery
within 24 hours after operation, the investigators record the number of patients who suffer from hematoma at the block point, and then calculate the incidence as: the number of patient suffering from hematoma at the block point/the total number in corresponding group
within 24 hours after surgery
incidence of infection at the block point in both two groups within 24 hours
Time Frame: within 24 hours after surgery
within 24 hours after operation, the investigators record the number of patients who suffer from infection at the block point, and then calculate the incidence as: the number of patient suffering from infection at the block point/the total number in corresponding group
within 24 hours after surgery
incidence of local anesthetic toxicity in both two groups within 24 hours
Time Frame: within 24 hours after surgery
within 24 hours after operation, the investigators record the number of patients who suffer from local anesthetic toxicity, and then calculate the incidence as: the number of patient suffering from local anesthetic toxicity/the total number in corresponding group
within 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TJ2012S152

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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