- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054469
Transversus Abdominus Plane Block
June 20, 2012 updated by: Mayo Clinic
Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: TAP block with placebo
|
20 ml of normal saline (placebo)
|
ACTIVE_COMPARATOR: TAP block with ropivacaine
|
20 ml of 0.5% ropivacaine hydrochloride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
February 1, 2012
Study Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (ESTIMATE)
January 22, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
June 21, 2012
Last Update Submitted That Met QC Criteria
June 20, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-003563
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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