Pain, Postoperative
Conditions
Keywords
dexmedetomidine, bupivacaine, quadratus lumborum block, postoperative pain, regional anesthesia, pediatric anesthesia
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.
Interventions
None listed
Sponsors
Istanbul University - Cerrahpasa
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time to first rescue analgesic requirement | 24 hours | the time to first rescue analgesic requirement within the first 24 postoperative hours, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed