Parecoxib as an Adjuvant to Scalp Nerve Blocks for Relief of Post-craniotomy Pain

June 12, 2020 updated by: Fang Luo, Beijing Tiantan Hospital

Pain is common for the first 2 days after major craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality.Pain after craniotomy derives from the scalp and pericranial muscles.Scalp block with local anesthesia seems to provide effective and safe anesthetic management.Scalp block can be performed by directly blocking the six different nerves that provide the sensory innervation of the scalp in neurological surgery.Even if adrenaline as an additive agent, scalp block using 0.5% or 0.75% bupivacaine with adrenaline could only improve postoperative analgesic for up to six hours after craniotomy.However, pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp nerve blocks does not seem to meet the requirements of craniotomy. Therefore, how to improve the quality and duration of scalp nerve blocks with local anesthetics is of great significance.Parecoxib is a NSAIDs that specifically inhibits the enzyme COX-2.Liu et al firstly applied parecoxib as an adjuvant to local anesthetics on peripheral nerve blocks and reported 20 mg parecoxib added to ropivacaine injected locally on the brachial plexus nerve prolonged the motor and sensory block times of the nerve blockade and ameliorated postoperative pain intensity for patients receiving forearm orthopaedic surgery. However, there has not been reported about local application of parecoxib on scalp nerve blocks. The investigators postulate that parecoxib may be also ideal for scalp nerve blocks for relief of post-craniotomy pain, and further research is needed.

The APONIA trial aims to establish whether scalp blocks with a mixture of ropivacaine plus parecoxib is able to relieve patients' postoperative pain compared with local anesthetics alone, thereby potentially changing medical practice.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

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

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 64 years
  • American Society of Anesthesiologists (ASA) physical status of I, II and III
  • Preoperative Glasgow Coma Scale (GCS) score of 15/15
  • Scheduled for elective craniotomy under general anesthesia

Exclusion Criteria:

  • Patients with chronic headache or chronic pain syndrome for any reason
  • Patients with psychiatric disorders, uncontrolled epilepsy, coagulopathy, infection around puncture point
  • Inability to understand and incapacity to use the pain scales before surgery
  • Pregnancy or at breastfeeding;
  • Participation in another intervention trial that interferes with the intervention or outcome of this trial
  • History of allergies to any of the study drugs
  • Refusal to participate or unable to acquire informed consent provided by the patients and/or legal guardian
  • Having their first craniotomy surgery with an occipital bone defect
  • Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, use of any painkiller within 24 hours before surgery
  • Extreme body mass index (BMI) (< 15 or > 35);

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The scalp blocks group
The scalp blocks group will receive scalp blocks with ropivacaine, 20ml, plus 10 mg parecoxib (diluted in 2 mL NS) with epinephrine (5 ug/mL) and i.v. saline 2ml;
Drug: Scalp blocks with ropivacaine plus parecoxib
Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus 10 mg parecoxib (diluted in 2 mL NS) with epinephrine at 1:200,000 (5 ug/mL) and i.v. saline 2ml;An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle by an independent researcher, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.
Active Comparator: The i.v. group
The i.v. group will receive scalp blocks with ropivacaine 20ml, plus saline 2ml with epinephrine (5 ug/mL) together with 10 mg parecoxib (diluted in 2 mL NS) intravenously.
Drug: Scalp blocks with ropivacaine and intravenous parecoxib
Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus saline 2ml with epinephrine at 1:200,000 (5 ug/mL) together with 10 mg parecoxib (diluted in 2 mL NS) intravenously. An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.
Active Comparator: The control group
The control group will receive scalp blocks with ropivacaine, 20ml, plus saline 2ml with epinephrine (5 ug/mL) and i.v. saline 2ml;
Drug: Scalp blocks with ropivacaine and intravenous saline
Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus saline 2ml with epinephrine at 1:200,000 (5 ug/mL) and i.v. saline 2ml. An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle by an independent researcher, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to the first rescue analgesic
Time Frame: Within 48 hours after the operation
Postoperatively, when the patient reports an NRS score of 4 or more or at the request of the patient, patients will be treated with morphine 2 mg intravenously as first rescue analgesic. Morphine 5 mg intravenously will be used as a second rescue analgesic if the NRS remained at 4 despite the use of morphine 2 mg.
Within 48 hours after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale of pain
Time Frame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
Pain will be assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable)
At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
Glasgow Coma Scale (GCS) score
Time Frame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (graded 1 in each element) is 3 (deep coma or death), while the highest is 15 (fully awake person).
At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
The doses of extra sufentanil boluses
Time Frame: During the surgery
Intraoperative analgesic requirement defined as extra sufentanil boluses required to blunt significant sympathetic response to surgical stimulation will be recorded.
During the surgery
Number of participates using extra sufentanil boluses
Time Frame: During the surgery
Intraoperative analgesic requirement defined as extra sufentanil boluses required to blunt significant sympathetic response to surgical stimulation will be recorded.
During the surgery
Number of participates with postoperative nausea and vomiting (PONV)
Time Frame: Within 48 hours postoperatively
Vomiting will be defined as the forceful expulsion of gastric contents, and nausea will be defined as an unpleasant sensation associated with the urge to vomit.
Within 48 hours postoperatively
Number of participates with bradycardia
Time Frame: Within 48 hours postoperatively
An above 20% of decrease in heart rate from baseline values will be considered as clinically significant.
Within 48 hours postoperatively
Number of participates with hypotension
Time Frame: Within 48 hours postoperatively
An above 20% of decrease in blood pressure from baseline values will be considered as clinically significant
Within 48 hours postoperatively
The time during PACU
Time Frame: Approximately 2 hours after the surgery
Patients will be transferred to the postoperative care unit (PACU) after extubation. A modified Aldrete score > 9 will be required for discharge from the PACU to a ward. The time during PACU is defined as the duration in the PACU after surgery
Approximately 2 hours after the surgery
Length of stay (LOS)
Time Frame: Approximately 2 weeks after the surgery
LOS is defined as the number of nights spent in the hospital after surgery
Approximately 2 weeks after the surgery
Adverse Events
Time Frame: Approximately 2 weeks after the surgery
An AE will be defined as any untoward medical occurrence, such as local hematoma, nerve injury, intra-arterial injection, allergic or toxic reaction, deriving facial nerve paralysis from scalp block.
Approximately 2 weeks after the surgery
Serious adverse events (SAEs)
Time Frame: Approximately 2 weeks after the surgery
Serious adverse events (SAEs) will include death, immediately life-threatening conditions, coma, inpatient hospitalization or prolongation of existing hospitalization, et al.
Approximately 2 weeks after the surgery
patient satisfaction score (PSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
Patient satisfaction will be assessed by the patient satisfaction score (PSS) (0 for unsatisfactory and 10 for very satisfactory)
At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 12, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2018-034-02-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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