The Analgesic Efficacy of Perineural Nalbuphine as an Adjuvant to Bupivacaine in Ultrasound Guided Superficial Cervical Plexus Nerve Block for Thyroid Surgeries. A Double Blinded Randomized Controlled Trial.

October 7, 2024 updated by: Omnia Yahia El Sayed Kamel, Cairo University
This study aiming to evaluate the analgesic effect of adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries regarding first rescue analgesia in the first twenty-four hours postoperative, VAS score after extubation and complications such as postoperative nausea, vomiting and respiratory depression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroidectomy is a common and painful procedure demanding analgesia. Patients may experience discomfort in swallowing, burning sensation in the throat, nausea, and vomiting, which are all caused by the surgical procedures or general anaesthesia. Thyroid surgeries induce brief postoperative pain caused by several mechanisms. One of the mechinsims of this Post-operative pain, believed to be due to the interruption of the rich nerve supply present in the neck.

A lot of drugs have been used to decrease this postoperative pain such as non-steroidal anti inflammatory drugs , opioids or regional blocks. Traditionally, opioids have been the mainstay of postoperative analgesia, specifically at thyroid and parathyroid surgical centers, where narcotic analgesics make up the major component of their postoperative pain control regimens. However, the use of opioids has been linked to an increased risk of postoperative complications that include ventilatory depression, sedation, postoperative nausea and vomiting (PONV), pruritis, difficulty of voiding, ileus and surgical site infections which can in turn contribute to delayed hospital discharge. Further acute and chronic opioids can have significant effects on the endocrine system. Longer-term use of opioids may lead to dependence and substance abuse disorder.

The skin overlying the neck, ear, angle of the mandible, shoulder, and clavicle is supplied by the superficial cervical plexus (SCP), which is a sensory neural plexus formed from the ventral rami of the first four cervical nerves (C1-C4). It emerges behind the posterior border of sternomastoid muscle.

Bilateral superficial cervical plexus block (SCPB) has shown good intraoperative and postoperative analgesia in upper neck surgeries especially in thyroidectomies, this regional block can be facilitated by using ultrasound guided technique as it provides good visualisation of the anatomical structures and decreases the complications.

There has always been a search for ideal adjuvants in peripheral nerve blocks which prolong the duration of analgesia with lesser adverse effects, Recently, nalbuphine was studied frequently as an adjuvant to local anesthetics in spinal and epidural and the results of all studies concluded that nalbuphine is effective when used as an adjuvant to local anaesthetics in spinal and epidural as it significantly prolongs the block duration.

The mechanism of perineural nalbuphine has not been clearly identified till now, previous studies demonstrated underlying mechanism could be interpreted that inflammatory response increases the synthesis of opioid receptors in the dorsal root ganglion neurons and enhances axonal transport and accumulation of opioid receptors in the sensory nerve endings in the inflamed tissue. Moreover, nalbuphine is an opioid receptors antagonist that allows for the peripheral analgesic effects of opioids in addition to the analgesic effect of its systemic absorption.

However, nalbuphine has not been studied extensively as an additive for peripheral nerve blocks as there was a minor research about it as an adjuvant to bupivacaine in brachial plexus block for upper limb surgeries and it showed that it prolongs the duration of sensory and motor blockades and reduces the requirement of analgesics in postoperative period. The superficial cervical block is a sensory block carrying sensory nerve fibers only with different axonal chemistry .

To our knowledge, no study till date compared the analgesic effect of perineural nalbuphine as an adjuvant to the superficial cervical block.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2

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

  • Egypt
    • الجيزة
      • Giza, الجيزة, Egypt, 1111
        • Recruiting
        • Kasr Alainy Teaching Hospitals
        • Contact:
        • Sub-Investigator:
          • Sara M Badie, Master
        • Principal Investigator:
          • Nashwa Nabil, Professor
        • Sub-Investigator:
          • Marwa M Zayed, Ass professor
        • Sub-Investigator:
          • Amany Eissa, Doctorate
        • Sub-Investigator:
          • Omnia Y Kamel, Doctorate

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged between 18 to 60 years old of both sexes undergoing elective thyroid surgery.
  • ASA I and II.

Exclusion Criteria:

  • Patient refusal.
  • Hypersensitivity or contraindication to nalbuphine or bupivacaine.
  • Pregnancy or lactating mothers.
  • Hepatic, cardiac or renal diseases.
  • Bleeding disorders.
  • Severe neurological or psychological disorders.
  • Goitres with retrosternal extension.
  • Any anatomical disruption in the neck (ex: metastatic lymph nodes).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group (C) control group
Patients will receive bilateral superficial cervical plexus block with 28 ml bupivacine 0.25% mixed with 2 ml saline 0.9%, to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia.
Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block
Adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries
Active Comparator: Group (N) Perineural Nalbuphine
Patients will receive bilateral superficial cervical plexus block with 28 ml Bupivacaine 0.25% mixed with 10 mg nalbuphine in saline 0.9% to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia.
Drug: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block
Adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours.
Time Frame: First 24 hours postoperative
defined as the time interval between the end of surgery and the first request to postoperative Nalbuphine
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative hemodynamics
Time Frame: every 10 minutes until the end of the surgery
mean arterial blood pressure
every 10 minutes until the end of the surgery
VAS score after extubation
Time Frame: at 0,2,6,12,18 and 24 hours after completion of surgery.
Visual Analogue Scale (VAS) measures pain intensity.
at 0,2,6,12,18 and 24 hours after completion of surgery.
Total amount of nalbuphine administrated to the patient 24 hours postoperative.
Time Frame: Every one hour postoperative for 24 hours
As analgesia
Every one hour postoperative for 24 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Marwa M Zayed, Assistant professor, Cairo University
  • Study Director: Amany Eissa, Doctorate, Cairo University
  • Study Director: Omnia Y Kamel, Doctorate degree, Cairo University

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)

July 15, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nerve blocks

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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