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Completed

NCT Number: NCT05435833

Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief

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

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, Gharbia Governorate, 31599, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral ultrasound guided GPN block

Procedure

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.

Primary outcomes

  1. Onset of 1st analgesic request

    Time frame: up to 24 hours postoperative

    the time to first analgesic request will be recorded

Secondary outcomes

  1. 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

  2. Postoperative rescue analgesic consumption

    Time frame: up to 24hours postoperative

    Total 24 hours postoperative rescue analgesic consumption

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Aliaa Muhammad Belal
  • Gehan Morsy Eid
  • Mohamed Shebl Abdelghany

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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