Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 74
- Primary Endpoint
- FLACC pediatric pain scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled in the study and were randomized using closed envelope method.
Eligibility Criteria
- Ages
- 1 Year to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) status I/II
- •Children between 1 to 8 years of age
- •Patients undergoing unilateral inguinal hernia repair surgery
Exclusion Criteria
- •Denial of parents
- •Patients who are allergic to local anesthetics
Arms & Interventions
TAP block with 1 mg.kg-1 bupivacaine 0.25%
Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block
Intervention: 1 mg.kg-1 bupivacaine 0.25% (Drug)
TAP block with 1 mg.kg-1 bupivacaine 0.125%
Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block
Intervention: 1 mg.kg-1 bupivacaine 0.125% (Drug)
Outcomes
Primary Outcomes
FLACC pediatric pain scores
Time Frame: 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 Outcomes
- Total analgesic requirement(up to 24 hours)
- First analgesic requirement time(up to 24 hours)
- Incidence of side effects(up to 24 hours)
- The length of hospital stay(up to 24 hours)
- Incidence of complications(up to first week.)
Investigators
Meltem Savran Karadeniz
Associate Professor
Istanbul University