Transversus Abdominus Plane Block
Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
1 other identifier
interventional
21
1 country
1
Brief Summary
Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 21, 2012
June 1, 2012
1.9 years
January 20, 2010
June 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.
24 hours postoperatively
Secondary Outcomes (1)
TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital
24 hours postoperatively
Study Arms (2)
TAP block with placebo
PLACEBO COMPARATORTAP block with ropivacaine
ACTIVE COMPARATORInterventions
20 ml of 0.5% ropivacaine hydrochloride
Eligibility Criteria
You may qualify if:
- Patients who are ≥ 18 and ≤ 80 years of age.
- Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.
You may not qualify if:
- Patients scheduled to undergo an open procedure for nephrectomy
- Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
- Bilateral nephrectomy
- Pregnant or lactating patients
- Patients unable or unwilling to provide informed consent
- Patients unable to comprehend the use of a visual analog scale
- Patients desiring preemptive antiemetics
- Opioid tolerance
- Allergy to amide local anesthetics or any of the study drugs (morphine).
- Contraindication to regional nerve block (bleeding disorder, infection at site of block)
- Patients with history of dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Aniskevich, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
June 21, 2012
Record last verified: 2012-06