Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Completed

CT.gov ID

NCT05979376

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study

Actual Study Start Date :

Dec 1, 2022

Actual Primary Completion Date :

Apr 1, 2023

Actual Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group I (Control group) group I: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg
Group II groupII: quadratus lumborum block with 0,25%bupivacaine 0,5 ml/kg and dexmedetomidine 0,5 mcg/kg as an adjuvant
Group III groupIII: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg and dexmedetomidine 1 mcg/kg as an adjuvant

Outcome Measures

Primary Outcome Measures

the time to first rescue analgesic requirement [24 hours]
the time to first rescue analgesic requirement within the first 24 postoperative hours,

Secondary Outcome Measures

postoperative pain scores FLACC [24 hours]
postoperative pain assessment score in children
additional analgesic consumption [24 hours]
total analgesic consuption within 24 hours
postoperative sedation scores RAMSEY [1 hour]
patient's sedation scores within postoperative first one hour
incidence of complications [24 hours]
Incidence of intraoperative and postoperative complications or side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The study included children aged 1-7 years with ASA (American Society of Anesthesiologists) I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy, hydrocele) with the consent of their families

Exclusion Criteria:

Children who were aged outside the range of 1-7 years, with ASA III or higher, allergic to local anesthetics, had an infection in the injection area, had contraindications for regional anesthesia such as coagulopathy, whose families did not give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery, had a body mass index of >30 kg/m2, and were expected to be admitted to the intensive care unit during the postoperative period were excluded from the study