Comparison of Epidural and TAP Block in Abdominal Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Thomas Nicholas IV MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01848951
First received: April 25, 2013
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in the literature (McDonnell 2007) (Kadam 2011), but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.


Condition Intervention
Pain Management
General Surgery
Drug: Epidural
Drug: TAP Block

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Difference between the two in terms of pain scores andopioid consumption [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epidural Drug: Epidural
TAP Block Drug: TAP Block

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult subjects undergoing major abdominal surgery

Criteria

Inclusion Criteria:

  • subject >/= 19 years of age
  • Undergoing major abdominal surgery
  • able to provide written informed consent

Exclusion Criteria:

  • chronic opioid use
  • allergies to amide anesthetics
  • inability to undergo general anesthesia
  • pregnancy
  • any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
  • or evidence of gross neurological dysfunction of the lower extremity
  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: NCT01848951

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68105
Contact: Stacey L Therrien, BS    402-559-2905    stherrien@unmc.edu   
Sponsors and Collaborators
University of Nebraska
  More Information

No publications provided

Responsible Party: Thomas Nicholas IV MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01848951     History of Changes
Other Study ID Numbers: 287.13.FB
Study First Received: April 25, 2013
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014