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CompletedNCT05513209Updated Sep 21, 2023

Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

An interventional study of opioid based multimodal anesthesia and pterygopalatine ganglion block based multimodal anesthesia) in PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING and DECREASE POSTOPERATIVE HOSPITAL STAY, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 13 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
4 Years to 13 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • PREVENTION OF POSTTONSILLECTOMY PAIN
  • DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING
  • DECREASE POSTOPERATIVE HOSPITAL STAY
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • Procedureopioid based multimodal anesthesia

    elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

  • Procedurepterygopalatine ganglion block based multimodal anesthesia)

    elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

06

What researchers measure

Primary outcomes

  1. postoperative VAS score

    Time frame: EVERY HOUR AFTER SURGERY FOR 24 HOURS

Secondary outcomes

  1. TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY

    Time frame: 24 HOURS AFTER SURGERY

  2. INTRAOPERATIVE BLOOD PRESSURE

    Time frame: EVERY 10 MINUTES up to 1 hour

  3. INTRAOPERATIVE HEART RATE

    Time frame: EVERY 10 MINUTES up to 1 hour

  4. TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS

    Time frame: DURING SURGERY

  5. length of PACU stay

    Time frame: one day after operation

07

Study locations

1 site
  • Ramymahrose
    Cairo, 20, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05513209
Responsible party
RAMY AHMED (Assistant Professor of Anesthesia, Ain Shams University) — Principal investigator
First posted
Aug 24, 2022
Start date
Sep 1, 2022
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Sep 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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