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

NCT04202367 | Completed

• 1 other identifier: 2016/1281
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transversus Abdominis Plane Block

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total analgesic requirement

  up to 24 hours

• First analgesic requirement time

  up to 24 hours

• Incidence of side effects

  up to 24 hours

• The length of hospital stay

  up to 24 hours

• Incidence of complications

  up to first week.

Study Arms (2)

TAP block with 1 mg.kg-1 bupivacaine 0.25%

ACTIVE COMPARATOR

Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block

Drug: 1 mg.kg-1 bupivacaine 0.25%

TAP block with 1 mg.kg-1 bupivacaine 0.125%

ACTIVE COMPARATOR

Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block

Drug: 1 mg.kg-1 bupivacaine 0.125%

Interventions

1 mg.kg-1 bupivacaine 0.25% DRUG

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

Also known as: Marcaine

TAP block with 1 mg.kg-1 bupivacaine 0.25%

1 mg.kg-1 bupivacaine 0.125% DRUG

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

Also known as: Marcaine

TAP block with 1 mg.kg-1 bupivacaine 0.125%

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) status I/II
• Children between 1 to 8 years of age
• Patients undergoing unilateral inguinal hernia repair surgery

You may not qualify if:

• Denial of parents
• Patients who are allergic to local anesthetics

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (1)

• Karadeniz MS, Atasever AG, Salviz EA, Bingul ES, Ciftci HS, Dincer MB, Sungur MO. Transversus abdominis plane block with different bupivacaine concentrations in children undergoing unilateral inguinal hernia repair: a single-blind randomized clinical trial. BMC Anesthesiol. 2022 Nov 21;22(1):355. doi: 10.1186/s12871-022-01907-y.

  PMID: 36411426 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Meltem Savran Karadeniz, Assoc. Prof

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Emine Aysu Salviz, Assoc. Prof

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 17, 2019
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 17, 2019

Record last verified: 2019-12