Skip to main content
OpenTrials
Completed

NCT Number: NCT04202367

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 mg.kg-1 bupivacaine 0.25%

Drug

Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.

Other names: Marcaine

1 mg.kg-1 bupivacaine 0.125%

Drug

Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.

Other names: Marcaine

Primary outcomes

  1. 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

  1. Total analgesic requirement

    Time frame: up to 24 hours

    Tramadol

  2. First analgesic requirement time

    Time frame: up to 24 hours

    Duration of postoperative analgesia

  3. Incidence of side effects

    Time frame: up to 24 hours

    Nausea, vomiting, respiratory depression

  4. The length of hospital stay

    Time frame: up to 24 hours

    Hospitalisation hours

  5. Incidence of complications

    Time frame: up to first week.

    Hemotoma, infection

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.