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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04202367
Enrollment
74
Registered
2019-12-17
Start date
2016-11-01
Completion date
2017-07-01
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transversus Abdominis Plane Block

Keywords

Transversus abdominis plane block, Bupivacaine, Concentration, Postoperative analgesia, Inguinal hernia repair surgery

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.

Interventions

DRUG1 mg.kg-1 bupivacaine 0.25%

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

DRUG1 mg.kg-1 bupivacaine 0.125%

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled in the study and were randomized using closed envelope method.

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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FLACC pediatric pain scoresup to 24 hoursIt corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.

Secondary

MeasureTime frameDescription
Total analgesic requirementup to 24 hoursTramadol
First analgesic requirement timeup to 24 hoursDuration of postoperative analgesia
Incidence of side effectsup to 24 hoursNausea, vomiting, respiratory depression
The length of hospital stayup to 24 hoursHospitalisation hours
Incidence of complicationsup to first week.Hemotoma, infection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026