The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block

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

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.

Study Overview

• Status: Completed
• Conditions: Transversus Abdominis Plane Block
• Intervention / Treatment: Drug: 1 mg.kg-1 bupivacaine 0.25%; Drug: 1 mg.kg-1 bupivacaine 0.125%

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TAP block with 1 mg.kg-1 bupivacaine 0.25%; Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block	Drug: 1 mg.kg-1 bupivacaine 0.25%; Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.; Other Names: Marcaine
ACTIVE_COMPARATOR: TAP block with 1 mg.kg-1 bupivacaine 0.125%; Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block	Drug: 1 mg.kg-1 bupivacaine 0.125%; Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC pediatric pain scores	It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic requirement	Tramadol	up to 24 hours
First analgesic requirement time	Duration of postoperative analgesia	up to 24 hours
Incidence of side effects	Nausea, vomiting, respiratory depression	up to 24 hours
The length of hospital stay	Hospitalisation hours	up to 24 hours
Incidence of complications	Hemotoma, infection	up to first week.

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Meltem Savran Karadeniz, Assoc. Prof, Istanbul University; Study Chair: Emine Aysu Salviz, Assoc. Prof, Istanbul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Concentration; Bupivacaine; Postoperative analgesia; Transversus abdominis plane block; Inguinal hernia repair surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2016/1281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No