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NCT05979376Completed

Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block

Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study
Istanbul University - Cerrahpasa (IUC)ClinicalTrials.gov
Study focus
Disease/Condition
Pain, Postoperative
Study type
Observational
Sponsor & location
Primary sponsor
Istanbul University - Cerrahpasa (IUC)
Location
Istanbul, Turkey
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2022
End date
Apr 01, 2023
Enrollment
60 participants
Primary outcome

the time to first rescue analgesic requirement

Summary

This prospective double blinded study will be conducted over 60 pediatric patients ASA
 (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who
 will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3
 study groups: Control group that only received local anesthetics ( bupivacaine) Group II
 bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the
 dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.
 
 Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded.
 When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion
 bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose
 of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first
 2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were
 evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting,
 and other side effects were recorded if present.
 
 Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded
 within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative
 complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will
 be recorded.

ICD-10 classifications
During surgical operationDuring surgical operationDuring surgical operationPain, unspecifiedPostoperative intestinal obstruction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05979376
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05979376 through Pure Global AI's free database. This phase not specified trial is sponsored by Istanbul University - Cerrahpasa (IUC) and is currently Completed. The study focuses on Pain, Postoperative. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.