Clinical trial NCT04202367: The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block
Official title: Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transversus Abdominis Plane Block
Keywords: Transversus abdominis plane block
Bupivacaine
Concentration
Postoperative analgesia
Inguinal hernia repair surgery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ultrasound-guided TAP block was applied 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: FLACC pediatric pain scores
timeFrame: up to 24 hours
Secondary outcomes:
measure: Total analgesic requirement
timeFrame: up to 24 hours
measure: First analgesic requirement time
timeFrame: up to 24 hours
measure: Incidence of side effects
timeFrame: up to 24 hours
measure: The length of hospital stay
timeFrame: up to 24 hours
measure: Incidence of complications
timeFrame: up to first week.
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Emine Aysu Salviz, Assoc. Prof
role: STUDY_CHAIR
References: