Comparison of Epidural and TAP Block in Abdominal Surgery

NCT01848951 | Completed

• 1 other identifier: 0287-13-FB
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Arms (2)

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

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

Interventions

Epidural DRUG

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.

Also known as: local anesthetic

Epidural

TAP Block DRUG

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)

Also known as: transversus abdominis plane, abdominal muscle anesthesia

TAP Block

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects undergoing major abdominal surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Injections, Epidural; Anesthetics, Local

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Thomas A Nicholas, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: May 8, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)