Ramymahrose
Cairo, 20, Egypt
Completed
NCT Number: NCT05513209
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
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
Completed
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Conditions
Age range
4 year–13 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
opioid based multimodal anesthesia
Procedureelective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
pterygopalatine ganglion block based multimodal anesthesia)
Procedureelective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
Primary outcomes
-
postoperative VAS score
Time frame: EVERY HOUR AFTER SURGERY FOR 24 HOURS
Secondary outcomes
-
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
Time frame: 24 HOURS AFTER SURGERY
-
INTRAOPERATIVE BLOOD PRESSURE
Time frame: EVERY 10 MINUTES up to 1 hour
-
INTRAOPERATIVE HEART RATE
Time frame: EVERY 10 MINUTES up to 1 hour
-
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Time frame: DURING SURGERY
-
length of PACU stay
Time frame: one day after operation
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Official study title
Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Aug 24, 2022
- Registry last updated
- Sep 21, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.