Comparison of Epidural and TAP Block in Abdominal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 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: May 26, 2015
Last verified: May 2015
  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
Acute Pain
Surgery
Regional Anesthesia
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

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: February 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epidural
The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed.Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain UNMCs standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.
Drug: Epidural
TAP Block
The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound.2.The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants ( subcostal position x2 and lateral position x2)
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

Contacts
Contact: Lace D Petry, BSN 402-559-2905 lace.petry@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-4455
Contact: Thomas A Nicholas, MD    402-957-3758    tnichola@unmc.edu   
Contact: Lace D Petry, BSN    402-559-2905    lace.petry@unmc.edu   
Principal Investigator: Thomas A Nicholas, MD         
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: May 26, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 27, 2015