The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block
- Conditions
- Transversus Abdominis Plane Block
- Interventions
- Drug: 1 mg.kg-1 bupivacaine 0.25%Drug: 1 mg.kg-1 bupivacaine 0.125%
- Registration Number
- NCT04202367
- Lead Sponsor
- Istanbul University
- Brief Summary
This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (TAP) block for unilateral inguinal hernia repair. In recruited 74 patients; Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
- Detailed Description
Transversus abdominis plane (TAP) block is a safe and effective analgesia technique for paediatric patients. This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in paediatric patients undergoing ultrasound-guided TAP blocks for unilateral inguinal hernia repair surgery. Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled for this study after obtaining Institutional Ethics Committee approval and written informed consents from parents or legal guardians (2016/1281). Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- American Society of Anesthesiologists (ASA) status I/II
- Children between 1 to 8 years of age
- Patients undergoing unilateral inguinal hernia repair surgery
- Denial of parents
- Patients who are allergic to local anesthetics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAP block with 1 mg.kg-1 bupivacaine 0.25% 1 mg.kg-1 bupivacaine 0.25% Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block TAP block with 1 mg.kg-1 bupivacaine 0.125% 1 mg.kg-1 bupivacaine 0.125% Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block
- Primary Outcome Measures
Name Time Method FLACC pediatric pain scores up to 24 hours It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.
- Secondary Outcome Measures
Name Time Method Total analgesic requirement up to 24 hours Tramadol
First analgesic requirement time up to 24 hours Duration of postoperative analgesia
Incidence of side effects up to 24 hours Nausea, vomiting, respiratory depression
The length of hospital stay up to 24 hours Hospitalisation hours
Incidence of complications up to first week. Hemotoma, infection