Comparison of Epidural and TAP Block in Abdominal Surgery

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT01848951

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 (McDonnell 2007) (Kadam 2011), 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Surgery Regional Anesthesia	Drug: Epidural Drug: TAP Block

Study Design

Study Type:

Observational

Actual Enrollment :

72 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	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 UNMCs 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.2.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

Arm

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 UNMCs 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.2.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

Outcome Measures

Primary Outcome Measures

Difference between the two in terms of pain scores andopioid consumption [one year]

Secondary Outcome Measures

patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-4455

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Nicholas IV MD, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT01848951

Other Study ID Numbers:

287.13.FB

First Posted:

May 8, 2013

Last Update Posted:

Dec 19, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Acute Pain

Study Results

No Results Posted as of Dec 19, 2016