Transversus Abdominus Plane Block

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01054469
First received: January 20, 2010
Last updated: June 20, 2012
Last verified: June 2012
  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:


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
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, see Learn About Clinical Studies.

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 September 11, 2014