Comparison of Epidural and TAP Block in Abdominal Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848951
• Other study ID #: 0287-13-FB
• Status: Completed
• Start date: February 1, 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Regional Anesthesia
• Surgery

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Comparison of pain scores (0 = no pain to 10 = worst pain possible)	96 hours post-op
Primary	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	Comparison of 96-hour hospital stay costs	Comparison of 96-hour hospital stay cost between the interventions	96 hours post-op
Secondary	Comparison of urinary failure/catheter acquired infection rates	Comparison of urinary failure/catheter acquired infection rates between the interventions	96 hours post-op
Secondary	Comparison of hypotension rates	Comparison hypotension rates between the interventions	96 hours post-op