Comparison of Epidural and TAP Block in Abdominal Surgery

Completed

• Conditions: Regional Anesthesia; Acute Pain; Surgery
• Interventions: Drug: Epidural; Drug: TAP Block

• Registration Number: NCT01848951
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-05-05
• Study First Posted: 2013-05-08
• Study Start: 2014-02-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epidural	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.
TAP Block	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)

Primary Outcome Measures

Name	Time	Method
Pain scores	96 hours post-op	Comparison of pain scores (0 = no pain to 10 = worst pain possible)
Opioid Consumption in a 24-Hour period	96 hours post-op	A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions

Secondary Outcome Measures

Name	Time	Method
Comparison of 96-hour hospital stay costs	96 hours post-op	Comparison of 96-hour hospital stay cost between the interventions
Comparison of hypotension rates	96 hours post-op	Comparison hypotension rates between the interventions
Comparison of urinary failure/catheter acquired infection rates	96 hours post-op	Comparison of urinary failure/catheter acquired infection rates between the interventions

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States