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Clinical Trials/NCT04202367
NCT04202367
Completed
Not Applicable

Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study

Istanbul University0 sites74 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
1 mg.kg-1 bupivacaine 0.25%
Conditions
Transversus Abdominis Plane Block
Sponsor
Istanbul University
Enrollment
74
Primary Endpoint
FLACC pediatric pain scores
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
July 1, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Savran Karadeniz

Associate Professor

Istanbul University

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

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%

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%

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.)

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