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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gehan Morsy Eid
Aliaa Muhammad Belal
Mohamed Shebl Abdelghany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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