Comparison of Epidural and TAP Block in Abdominal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Acute Pain; Regional Anesthesia
• Intervention / Treatment: Drug: Epidural; Drug: TAP Block

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult subjects undergoing major abdominal surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.; Other Names: local anesthetic
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)	Drug: 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); Other Names: transversus abdominis plane, abdominal muscle anesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thomas A Nicholas, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: May 5, 2013
• First Posted (Estimated): May 8, 2013

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 0287-13-FB