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Transversus Abdominus Plane Block

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054469
First Posted: January 22, 2010
Last Update Posted: June 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
January 20, 2010
January 22, 2010
June 21, 2012
March 2010
February 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01054469 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Transversus Abdominus Plane Block
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Nephrectomy
  • Procedure: TAP block placement with placebo
    20 ml of normal saline (placebo)
  • Procedure: Placement of block with ropivacaine
    20 ml of 0.5% ropivacaine hydrochloride
  • Placebo Comparator: TAP block with placebo
    Intervention: Procedure: TAP block placement with placebo
  • Active Comparator: TAP block with ropivacaine
    Intervention: Procedure: Placement of block with ropivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01054469
08-003563
No
Not Provided
Not Provided
Stephen Aniskevich, III, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Stephen Aniskevich, MD Mayo Clinic
Mayo Clinic
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP