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Clinical Trials/NCT01848951
NCT01848951
Completed
Not Applicable

Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery

University of Nebraska1 site in 1 country72 target enrollmentFebruary 1, 2014

Overview

Phase
Not Applicable
Intervention
Epidural
Conditions
Acute Pain
Sponsor
University of Nebraska
Enrollment
72
Locations
1
Primary Endpoint
Pain scores
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.

Detailed Description

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, 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
December 1, 2016
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & 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 institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.

Intervention: Epidural

TAP Block

The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. 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)

Intervention: TAP Block

Outcomes

Primary Outcomes

Pain scores

Time Frame: 96 hours post-op

Comparison of pain scores (0 = no pain to 10 = worst pain possible)

Opioid Consumption in a 24-Hour period

Time Frame: 96 hours post-op

A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions

Secondary Outcomes

  • Comparison of 96-hour hospital stay costs(96 hours post-op)
  • Comparison of urinary failure/catheter acquired infection rates(96 hours post-op)
  • Comparison of hypotension rates(96 hours post-op)

Study Sites (1)

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