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

NCT ID: NCT04202367

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-07-01

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.

Conditions

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Transversus Abdominis Plane Block

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

1 mg.kg-1 bupivacaine 0.25%

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

1 mg.kg-1 bupivacaine 0.125%

Intervention Type DRUG

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

Interventions

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1 mg.kg-1 bupivacaine 0.25%

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

Intervention Type DRUG

1 mg.kg-1 bupivacaine 0.125%

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

Intervention Type DRUG

Other Intervention Names

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Marcaine Marcaine

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meltem Savran Karadeniz, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Emine Aysu Salviz, Assoc. Prof

Role: STUDY_CHAIR

Istanbul University

References

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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.

Reference Type DERIVED
PMID: 36411426 (View on PubMed)

Other Identifiers

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2016/1281

Identifier Type: -

Identifier Source: org_study_id