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

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: Active, not recruiting
• Conditions: Pain; Nerve Block
• Intervention / Treatment: Drug: nerve block with 0.5% ropivacaine; Other: without any nerve block

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
MAP 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	HR within 10 minutes after nerve block	within 10 minutes after nerve block
mean arterial pressure (MAP) before nerve block	mean arterial pressure (MAP) before nerve block	before nerve block
heat rate (HR) before nerve block	heat rate (HR) before nerve block	before nerve block
MAP before nasal mucosal dissection	MAP before nasal mucosal dissection	before nasal mucosal dissection
HR before nasal mucosal dissection	HR before nasal mucosal dissection	before nasal mucosal dissection
MAP immediately after nasal mucosal dissection	MAP immediately after nasal mucosal dissection	immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection	HR immediately after nasal mucosal dissection	immediately after nasal mucosal dissection
MAP before septum resection	MAP before septum resection	before septum resection
HR before septum resection	HR before septum resection	before septum resection
MAP immediately after septum resection	MAP immediately after septum resection	immediately after septum resection
HR immediately after septum resection	HR immediately after septum resection	immediately after septum resection
MAP before sella bone resection	MAP before sella bone resection	before sella bone resection
HR before sella bone resection	HR before sella bone resection	before sella bone resection
MAP after sella bone resection	MAP after sella bone resection	before sella bone resection
HR immediately after sella bone resection	HR immediately after sella bone resection	immediately after sella bone resection
MAP before dural incision of sella	MAP before dural incision of sella	before dural incision of sella
HR before dural incision of sella	HR before dural incision of sella	before dural incision of sella
MAP 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	HR immediately after dural incision of sella	immediately after dural incision of sella
MAP before exploration of pituitary fossa	MAP before exploration of pituitary fossa	before exploration of pituitary fossa
HR before exploration of pituitary fossa	HR before exploration of pituitary fossa	before exploration of pituitary fossa
MAP 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	HR immediately after exploration of pituitary fossa	immediately after exploration of pituitary fossa

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
incidence of postoperative nausea and vomiting (PONV) within 24 hours	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	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)	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	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	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	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	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	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	from the time of surgery beginning until end time of surgery	from the time of surgery beginning until end time of surgery
anesthesia time	from the time of anesthesia beginning until end time of anesthesia	from the time of anesthesia beginning until end time of anesthesia
awakening time	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 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	use dosage of anesthetic drug during operation	during surgery
urine volume	urine volume during surgery	during surgery
bleeding volume	bleeding volume during surgery	during surgery
maintenance infusion rate of remifentanil	infusion rate of remifentanil for maintaining effective analgesic effect during surgery	during surgery
the dosage of remedial painkillers (remifentanil)	the dosage of remedial painkillers (remifentanil) during surgery	during surgery
the dosage of remedial perdipine	the dosage of remedial perdipine during surgery	during surgery
the dosage of remedial esmolol	the dosage of remedial esmolol during surgery	during surgery
the time of initial administration of remedial antiemetics within 48 hours	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	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	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	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	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

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ANTICIPATED): September 28, 2023
• Study Completion (ANTICIPATED): September 28, 2023

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (ACTUAL): September 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID 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