Clinical trial NCT05979376: Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block
Official title: Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: dexmedetomidine
bupivacaine
quadratus lumborum block
postoperative pain
regional anesthesia
pediatric anesthesia
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patient children aged 1-7 years

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.


Eligibility criteria: 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

Primary outcomes:
measure: the time to first rescue analgesic requirement
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative pain scores FLACC (face, legs, activity, cry, and consolability)
timeFrame: 24 hours
measure: additional analgesic consumption
timeFrame: 24 hours
measure: postoperative sedation scores RAMSEY (Ramsey sedation scale)
timeFrame: 1 hour
measure: incidence of complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: PINAR Kendigelen
state: Please Select
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: PINAR Kendigelen, Prof.
role: STUDY_DIRECTOR
References: