Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

September 18, 2023 updated by: RAMY AHMED, Ain Shams University

Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations

intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Egypt
      • Cairo, Egypt, 20
        • Ramymahrose

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

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 4 to 13 years old.
  • Elective tonsillectomy or adenotonsillectomy surgery

Exclusion Criteria:

  • Allergies to xylocaine.
  • Developmental delays.
  • Significant cognitive impairment.
  • American Society of Anesthesiologists (ASA) Class 3 and 4.
  • Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: opioid based multimodal anesthesia
One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Procedure: opioid based multimodal anesthesia
elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Active Comparator: opioid free pterygopalatine ganglion block based multimodal anesthesia
One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
Procedure: pterygopalatine ganglion block based multimodal anesthesia)
elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative VAS score
Time Frame: EVERY HOUR AFTER SURGERY FOR 24 HOURS
EVERY HOUR AFTER SURGERY FOR 24 HOURS

Secondary Outcome Measures

Outcome Measure
Time Frame
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
Time Frame: 24 HOURS AFTER SURGERY
24 HOURS AFTER SURGERY
INTRAOPERATIVE BLOOD PRESSURE
Time Frame: EVERY 10 MINUTES up to 1 hour
EVERY 10 MINUTES up to 1 hour
INTRAOPERATIVE HEART RATE
Time Frame: EVERY 10 MINUTES up to 1 hour
EVERY 10 MINUTES up to 1 hour
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Time Frame: DURING SURGERY
DURING SURGERY
length of PACU stay
Time Frame: one day after operation
one day after operation

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

September 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006379 TON

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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