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TAP Versus Thoracic Epidural in Major Abdominal Resections

Primary Purpose

Malignant Neoplasm of Abdomen, Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exparel 1.33% (20ml Volume)

0.125% bupivicaine with 2 mcg/ml Fentanyl.

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Abdomen focused on measuring Surgery, Abdominal, Epidural Anesthesia, Transversus Abdominis Plane Block, TAP block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
Patient agrees to participate in this study and provides informed consent

Exclusion criteria:

Surgical cases combined with thoracic surgeries
Surgical cases where the abdominal operation is performed laparoscopically
Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
Adults unable to provide informed consent
Children
Pregnant women
Prisoners
Non-English speaking subjects
Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Sites / Locations

Spectrum Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Transversus Abdominis Plane Block

Thoracic Epidural Anesthesia

Arm Description

Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)

Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl

Outcomes

Primary Outcome Measures

Hypotension

The incidence of systolic blood pressure less than 90 mmHg and fluid requirements

Secondary Outcome Measures

Patient satisfaction relative to pain control and amount of additional narcotic usage

A short patient survey during the postoperative period which will collect information on pain management.

Full Information

NCT ID

NCT02197988

First Posted

May 13, 2014

Last Updated

April 16, 2018

Sponsor

Spectrum Health Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT02197988

Brief Title

TAP Versus Thoracic Epidural in Major Abdominal Resections

Official Title

Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 3, 2013 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spectrum Health Hospitals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing major surgery. The two methods being compared are the thoracic epidural and the TAP block. The thoracic epidural method involves medication being given through a patient's back and the TAP block involves medication being given through a patient's abdomen (belly). The investigators will compare side effects experienced by the patients that take part in this study, including a change in blood pressure, as well as the patients' opinions about their pain management experience after surgery.

Detailed Description

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method. This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study. Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care. Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm of Abdomen, Surgery

Keywords

Surgery, Abdominal, Epidural Anesthesia, Transversus Abdominis Plane Block, TAP block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transversus Abdominis Plane Block

Arm Type

Active Comparator

Arm Description

Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)

Arm Title

Thoracic Epidural Anesthesia

Arm Type

Active Comparator

Arm Description

Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl

Intervention Type

Drug

Intervention Name(s)

Exparel 1.33% (20ml Volume)

Other Intervention Name(s)

TAP Block, Transversus Abdominis Plane Block

Intervention Description

Transversus Abdominis Plane Block

Intervention Type

Drug

Intervention Name(s)

0.125% bupivicaine with 2 mcg/ml Fentanyl.

Other Intervention Name(s)

Epidural, Thoracic Epidural Anesthesia

Intervention Description

Thoracic Epidural Anesthesia

Primary Outcome Measure Information:

Title

Hypotension

Description

The incidence of systolic blood pressure less than 90 mmHg and fluid requirements

Time Frame

First 24-72 hours postoperatively

Secondary Outcome Measure Information:

Title

Patient satisfaction relative to pain control and amount of additional narcotic usage

Description

A short patient survey during the postoperative period which will collect information on pain management.

Time Frame

Post operative day two during hospitalization

Other Pre-specified Outcome Measures:

Title

Cost Evaluation

Description

Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.

Time Frame

Postoperative hospitalization an expected average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures Patient agrees to participate in this study and provides informed consent Exclusion criteria: Surgical cases combined with thoracic surgeries Surgical cases where the abdominal operation is performed laparoscopically Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations) Adults unable to provide informed consent Children Pregnant women Prisoners Non-English speaking subjects Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathew Chung, MD

Organizational Affiliation

Spectrum Health Hospitals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spectrum Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22286518

Citation

Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.

Results Reference

background

PubMed Identifier

22450529

Citation

Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.

Results Reference

background

PubMed Identifier

22476239

Citation

Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.

Results Reference

background

PubMed Identifier

22632762

Citation

Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.

Results Reference

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PubMed Identifier

21296242

Citation

Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

Results Reference

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PubMed Identifier

20376492

Citation

Conaghan P, Maxwell-Armstrong C, Bedforth N, Gornall C, Baxendale B, Hong LL, Carty HM, Acheson AG. Efficacy of transversus abdominis plane blocks in laparoscopic colorectal resections. Surg Endosc. 2010 Oct;24(10):2480-4. doi: 10.1007/s00464-010-0989-y. Epub 2010 Apr 8.

Results Reference

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PubMed Identifier

17179269

Citation

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.

Results Reference

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PubMed Identifier

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Citation

Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.

Results Reference

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PubMed Identifier

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Citation

Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.

Results Reference

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PubMed Identifier

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Citation

Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.

Results Reference

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PubMed Identifier

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Citation

Hilton AK, Pellegrino VA, Scheinkestel CD. Avoiding common problems associated with intravenous fluid therapy. Med J Aust. 2008 Nov 3;189(9):509-13. doi: 10.5694/j.1326-5377.2008.tb02147.x.

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Citation

Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.

Results Reference

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TAP Versus Thoracic Epidural in Major Abdominal Resections

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