Bupivacaine Pharmacokinetics Following TAP Block
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transversus Abdominis Plane Block
Intervention: Blood sample for bupivicaine pharmacokinetics (Other)
Phase: N/A
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Jason Hayes, Principal Investigator, Affiliation: The Hospital for Sick Children
Overall contact:
Jason Hayes, Phone: 416-813-8963, Email: jason.hayes@sickkids.ca
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.
Clinical Details
Official title: Bupivacaine Pharmacokinetics in Children Following Transversus Abdominis Plane Block
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Population pharmacokinetics of bupivacaine and 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.
Eligibility
Minimum age: 3 Months.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jason Hayes, Phone: 416-813-8963, Email: jason.hayes@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Additional Information
Starting date: September 2011
Last updated: May 29, 2015
|
