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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05513209
Enrollment
90
Registered
2022-08-24
Start date
2022-09-01
Completion date
2023-08-01
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 13 Years
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.

Design outcomes

Primary

MeasureTime frame
postoperative VAS scoreEVERY HOUR AFTER SURGERY FOR 24 HOURS

Secondary

MeasureTime frame
INTRAOPERATIVE HEART RATEEVERY 10 MINUTES up to 1 hour
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODSDURING SURGERY
length of PACU stayone day after operation
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY24 HOURS AFTER SURGERY
INTRAOPERATIVE BLOOD PRESSUREEVERY 10 MINUTES up to 1 hour

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026