Bupivacaine Pharmacokinetics Following TAP Block

Completed

• Conditions: Transversus Abdominis Plane Block
• Interventions: Other: Blood sample for bupivicaine pharmacokinetics

• Registration Number: NCT02015182
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The aims of this study are to determine population PK parameters of bupivacaine in children following TAP block using a population-based PK approach, and to evaluate the influence of patient covariates on drug disposition.

Detailed Description

The number of published pediatric studies on the use of transversus abdominis plane (TAP) block has increased in recent years. The transversus abdominis plane (TAP) block has been used for postoperative analgesia for surgery to the abdominal wall and involves the injection of local anesthetic solution into a plane between internal oblique (IO) and transversus abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in instances of non-midline abdominal incision and is particularly useful in cases where epidural blockade is either contraindicated or technically or logistically not feasible. Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after TAP block in children. The aims of this study are to determine population pharmacokinetic (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK approach.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-19
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients receiving a TAP block as part of routine anesthetic management
• Patients older than 3 months and less than 18 years of age
• Patients weighing ≥ 6 kg
• Patients with American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria

• Patients with known severe preexisting liver disease
• Patients with known severe (i.e. requiring dialysis) preexisting renal disease
• Patients who will be discharged the day of surgery
• Refusal to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood sample for bupivicaine pharmacokinetics	Blood sample for bupivicaine pharmacokinetics	Children undergoing TAP block will have blood sampled for bupivacaine pharmacokinetics

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition	0 - 360 minutes after the TAP block is performed	Blood will be drawn from an indwelling intravenous catheter. Each patient will have a total of 6 samples collected during each of the following time blocks: 0 - 10 minutes, 11 - 20 minutes, 21 - 30 minutes, 31 - 60 minutes, 61 - 180 minutes and 181 - 360 minutes after the TAP block is performed. Age, weight, sex, concomitant drugs (intravenous and inhalation anesthetics, muscle relaxants, and opioids), and kidney function data will be investigated as co-variables for each of the primary parameters. We will obtain estimates of total clearance (CL), volume of distribution, elimination half life (t1/2), estimates of clearance, and absorption rate constant.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada