- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513209
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 20
- Ramymahrose
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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.
|
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
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EVERY HOUR AFTER SURGERY FOR 24 HOURS
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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
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EVERY 10 MINUTES up to 1 hour
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INTRAOPERATIVE HEART RATE
Time Frame: EVERY 10 MINUTES up to 1 hour
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EVERY 10 MINUTES up to 1 hour
|
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Time Frame: DURING SURGERY
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DURING SURGERY
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length of PACU stay
Time Frame: one day after operation
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one day after operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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