Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief

May 5, 2023 updated by: Mona Blough El Mourad, Tanta University

Ultrasound-Guided Submandibular Parapharyngeal Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief in Adults. A Prospective Randomized Study

The aim of the present study is to evaluate the efficacy and safety of Ultra-sound guided submandibular parapharyngeal glossopharyngeal nerve block as regards time for first need of analgesic as a primary outcome as well as pain score, total postoperative analgesic requirement, and incidence of complications as secondary outcomes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tonsillectomy is one of the most frequent surgical procedures performed all over the world that has been identified as being severely painful especially in the adult population. Management of post tonsillectomy pain is of paramount importance in order to improve swallowing and enhance oral intake as well as to decrease the risk of dehydration, infection and secondary hemorrhage with a subsequent hastening of recovery.

A variety of analgesic regimens have been implemented to alleviate post-tonsillectomy pain, however; no consensus on the ideal analgesic regimen has been yet identified.

The Ultrasound (US)-guided glossopharyngeal nerve (GPN) block has been acknowledged as a feasible option for providing perioperative analgesia in tonsillectomy patients. It blocks sensory impulses from the posterior third of the tongue, palatine tonsil, and mucous membranes of the mouth and pharynx. Conventional techniques for blocking the GPN carry the risk of vascular puncture, inadvertent block of closely adjacent other cranial nerves, with increased probability of local anesthetic toxicity and even upper airway obstruction. Recently, a novel, safe, and reproducible US-guided GPN block technique has been introduced by Azman et al, which would block the GPN distally, in the tissue plane just next to the pharyngeal wall and relatively far from high risk nearby structures.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31599
        • Recruiting
        • Tanta University 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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients classified by the American society of Anesthesiologists ASA I and II patients
  • Scheduled for tonsillectomy procedure

Exclusion Criteria:

  • Patients' refusal
  • History of diabetes mellitus,
  • Cardiac, liver or renal impairment
  • Obstructive sleep apnea syndrome
  • Swallowing difficulty
  • Intake of chronic pain medications or substance abuse
  • Bleeding disorders
  • Hypersensitivity to the used medication

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (glossopharyngeal nerve block group)
bilateral ultrasound guided GPN block will be performed after induction of anesthesia and pre incisional by an experienced anesthesiologist
Procedure: bilateral ultrasound guided GPN block
a linear high frequency ultrasound probe will be initially positioned over the hyoid bone in the transverse plane, then the probe will be rotated to keep in line with the mandibular angle and the pharyngeal wall is identified by US. Using an in plane approach, a 22 G ,5 cm needle will be advanced till it reaches just superficial to the pharyngeal wall and 2.2 ml of 0.25% bupivacaine will be injected.
No Intervention: Group II(Control group)
general anesthesia alone (no block)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of 1st analgesic request
Time Frame: up to 24 hours postoperative
the time to first analgesic request will be recorded
up to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative
The numerical rating scale for pain ranging from 0-10 where the minimum value of 0 represents no pain and the maximum value of 10 represent the worst pain imaginable
at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative
Postoperative rescue analgesic consumption
Time Frame: up to 24hours postoperative
Total 24 hours postoperative rescue analgesic consumption
up to 24hours postoperative

Collaborators and Investigators

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

Sponsor

Tanta University

Collaborators

Gehan Morsy Eid
Aliaa Muhammad Belal
Mohamed Shebl Abdelghany

Investigators

  • Principal Investigator: Mona B El Mourad, MD, Tanta University

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)

November 5, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 18, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GPN block in tonsillectomy

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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