Transversus Abdominus Plane Block - Full Text View

Purpose

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	Intervention
Nephrectomy	Procedure: TAP block placement with placebo Procedure: Placement of block with ropivacaine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.

Resource links provided by NLM:

Drug Information available for: Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	March 2010
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Stephen Aniskevich, III, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01054469 History of Changes
Other Study ID Numbers:	08-003563
Study First Received:	January 20, 2010
Last Updated:	June 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

nephrectomy

Additional relevant MeSH terms:

Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013