Clincosm LogoSign in Get a demo

Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513209
Collaborator
(none)
200
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: opioid based multimodal anesthesia
  • Procedure: pterygopalatine ganglion block based multimodal anesthesia)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. postoperative VAS score [EVERY HOUR AFTER SURGERY FOR 24 HOURS]

Secondary Outcome Measures

  1. TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY [24 HOURS AFTER SURGERY]

  2. INTRAOPERATIVE BLOOD PRESSURE [EVERY 10 MINUTES up to 1 hour]

  3. INTRAOPERATIVE HEART RATE [EVERY 10 MINUTES up to 1 hour]

  4. TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS [DURING SURGERY]

  5. length of PACU stay [one day after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RAMY AHMED, Assistant Professor of Anesthesia, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05513209
Other Study ID Numbers:
  • IRB00006379 TON
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ganglion Cysts
Nausea
Anesthetics

Study Results

No Results Posted as of Aug 24, 2022