ClinicalTrials.gov
ClinicalTrials.gov Menu

Transversus Abdominus Plane Block

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.
ClinicalTrials.gov Identifier: NCT01054469
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : June 21, 2012
Sponsor:
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Nephrectomy Procedure: TAP block placement with placebo Procedure: Placement of block with ropivacaine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
Study Start Date : March 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: TAP block with placebo Procedure: TAP block placement with placebo
20 ml of normal saline (placebo)
Active Comparator: TAP block with ropivacaine Procedure: Placement of block with ropivacaine
20 ml of 0.5% ropivacaine hydrochloride



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 24 hours postoperatively ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054469


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephen Aniskevich, MD Mayo Clinic

Responsible Party: Stephen Aniskevich, III, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01054469     History of Changes
Other Study ID Numbers: 08-003563
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Mayo Clinic:
nephrectomy

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents