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Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

Primary Purpose

PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, DECREASE POSTOPERATIVE HOSPITAL STAY

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
opioid based multimodal anesthesia
pterygopalatine ganglion block based multimodal anesthesia)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PREVENTION OF POSTTONSILLECTOMY PAIN

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ramymahrose

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

opioid based multimodal anesthesia

opioid free pterygopalatine ganglion block based multimodal anesthesia

Arm Description

One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid 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.

Outcomes

Primary Outcome Measures

postoperative VAS score

Secondary Outcome Measures

TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
INTRAOPERATIVE BLOOD PRESSURE
INTRAOPERATIVE HEART RATE
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
length of PACU stay

Full Information

First Posted
August 16, 2022
Last Updated
September 18, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05513209
Brief Title
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
Official Title
Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, DECREASE POSTOPERATIVE HOSPITAL STAY

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
opioid based multimodal anesthesia
Arm Type
Active Comparator
Arm Description
One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Arm Title
opioid free pterygopalatine ganglion block based multimodal anesthesia
Arm Type
Active Comparator
Arm Description
One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
opioid based multimodal anesthesia
Intervention Description
elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
pterygopalatine ganglion block based multimodal anesthesia)
Intervention Description
elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
Primary Outcome Measure Information:
Title
postoperative VAS score
Time Frame
EVERY HOUR AFTER SURGERY FOR 24 HOURS
Secondary Outcome Measure Information:
Title
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
Time Frame
24 HOURS AFTER SURGERY
Title
INTRAOPERATIVE BLOOD PRESSURE
Time Frame
EVERY 10 MINUTES up to 1 hour
Title
INTRAOPERATIVE HEART RATE
Time Frame
EVERY 10 MINUTES up to 1 hour
Title
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Time Frame
DURING SURGERY
Title
length of PACU stay
Time Frame
one day after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ramymahrose
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

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Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

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