Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT05979376
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-07-29
• Status Verified: 2023-08
• Study First Posted: 2023-08-07
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
postoperative pain scores FLACC (face, legs, activity, cry, and consolability)	24 hours	postoperative pain assessment score in children (The scale is scored in a range of 0-10 with 0 representing no pain, 10 representing maximum pain)
additional analgesic consumption	24 hours	total analgesic consuption within 24 hours
postoperative sedation scores RAMSEY (Ramsey sedation scale)	1 hour	patient's sedation scores within postoperative first one hour (Ramsey sedation score is scored in a range of 1-6 with 1 representing awake; agitated or restless, 6 representing Asleep; no response to glabellar tap or loud auditory stimulus)
incidence of complications	24 hours	Incidence of intraoperative and postoperative complications or side effects

Trial Locations

Locations (1)

PINAR Kendigelen; 🇹🇷 Istanbul, Please Select, Turkey