Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: opioid based multimodal anesthesia
* Procedure: pterygopalatine ganglion block based multimodal anesthesia)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative VAS score |  | EVERY HOUR AFTER SURGERY FOR 24 HOURS | 

Secondary Outcome Measures

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