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

Transversus Abdominis Plane Block Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202367
• Other study ID #: 2016/1281
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: December 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Transversus Abdominis Plane Block

Intervention

Drug:
• 1 mg.kg-1 bupivacaine 0.25%
Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.
• 1 mg.kg-1 bupivacaine 0.125%
Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

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