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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transversus Abdominis Plane Block

Intervention / Treatment
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* Drug: 1 mg.kg-1 bupivacaine 0.25%
* Drug: 1 mg.kg-1 bupivacaine 0.125%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block with 1 mg.kg-1 bupivacaine 0.25%<br>Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block | Drug: 1 mg.kg-1 bupivacaine 0.25%<br>* Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.<br>* Other names: Marcaine;|
| Active Comparator: TAP block with 1 mg.kg-1 bupivacaine 0.125%<br>Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block | Drug: 1 mg.kg-1 bupivacaine 0.125%<br>* Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.<br>* Other names: Marcaine;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus abdominis plane block, Bupivacaine, Concentration, Postoperative analgesia, Inguinal hernia repair surgery