Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery

NCT02591407 | Completed Results

• 1 other identifier: HSR 15-1618
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.

Conditions

Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Keywords

Continuous Epidural Analgesia; Transversus Abdominis Plane block

Outcome Measures

Primary Outcomes (2)

• Post-operative Mean Numeric Pain Scale.

  Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.

  Post-operative day 0,1,2,3

• Overall Benefits of Analgesia Score (OBAS)

  Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. 1\. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale). 7\. Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst). Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.

  Post-operative day 0,1,2,3

Secondary Outcomes (5)

• Patient Use of Narcotic Analgesia Post-op Day 0

  Post-operative day 0

• Patient Use of Narcotic Analgesia Post-operative Day 0

  Post-operative day 0

• Patient Use of Narcotic Analgesia Post-operative Day 3

  Post-operative day 3

• Patient Use of Narcotic Analgesia Post-operative Day 1

  Post-operative day 1

• Patient Use of Narcotic Analgesia Post-operative Day 2

  Post-operative day 2

Study Arms (2)

TAP Block- Exparel

ACTIVE COMPARATOR

Transversus abdominis plane block utilizing the medication Exparel®

Procedure: TAP Block

Continuous Epidural Analgesia

ACTIVE COMPARATOR

Continuous Epidural Analgesia

Procedure: Continuous Epidural Analgesia

Interventions

TAP Block PROCEDURE

This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles

Also known as: Exparel

TAP Block- Exparel

Continuous Epidural Analgesia PROCEDURE

Epidural catheter placed prior to the operation in the standard fashion

Continuous Epidural Analgesia

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum;
• Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic);
• Patients \> 18 years of age;
• Able to provide informed written consent
• Patients capable of completing questionnaires at the time of consent

You may not qualify if:

• Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl;
• Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated International Normalized Ratio (INR), anticoagulation, patient refusal, etc) or TAP block (patient refusal);
• Urgent or emergent surgery precluding epidural catheter placement or TAP block;
• Systemic Infection contraindicating epidural catheter placement or TAP block;
• Unwillingness to participate in follow up assessments;
• Prisoners
• Pregnant women

Sponsors & Collaborators

• Trinity Health Michigan: lead

Study Sites (1)

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.

  PMID: 30192328 DERIVED

Related Links

• American Society of Colon and Rectal Surgeons

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Robert Cleary
• Organization: St. Joseph Mercy Hospital Ann Arbor

Robert.Cleary@trinity-health.org

7347128150

Study Officials

• Robert K Cleary, MD

  Saint Joseph Mercy Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colon and Rectal Surgeon

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 29, 2015
• Study Start: January 12, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)