TAP Versus Thoracic Epidural in Major Abdominal Resections

NCT02197988 | Completed

• 1 other identifier: 2013-218
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm of Abdomen; Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hypotension

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

  First 24-72 hours postoperatively

Secondary Outcomes (1)

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

  Post operative day two during hospitalization

Other Outcomes (1)

• Cost Evaluation

  Postoperative hospitalization an expected average of 6 months

Study Arms (2)

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

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

Drug: Exparel 1.33% (20ml Volume)

Thoracic Epidural Anesthesia

ACTIVE COMPARATOR

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

Drug: 0.125% bupivicaine with 2 mcg/ml Fentanyl.

Interventions

Exparel 1.33% (20ml Volume) DRUG

Transversus Abdominis Plane Block

Also known as: TAP Block, Transversus Abdominis Plane Block

Transversus Abdominis Plane Block

0.125% bupivicaine with 2 mcg/ml Fentanyl. DRUG

Thoracic Epidural Anesthesia

Also known as: Epidural, Thoracic Epidural Anesthesia

Thoracic Epidural Anesthesia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (12)

• 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.

  PMID: 22286518 BACKGROUND

• 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.

  PMID: 22450529 BACKGROUND

• 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.

  PMID: 22476239 BACKGROUND

• 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.

  PMID: 22632762 BACKGROUND

• 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.

  PMID: 21296242 BACKGROUND

• 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.

  PMID: 20376492 BACKGROUND

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 22967210 BACKGROUND

• 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.

  PMID: 22312327 BACKGROUND

• 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.

  PMID: 14739801 BACKGROUND

• 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.

  PMID: 18976194 BACKGROUND

• 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.

  PMID: 21457153 BACKGROUND

MeSH Terms

Interventions

Fentanyl; Injections, Epidural

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mathew Chung, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: July 23, 2014
• Study Start: December 3, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)