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

May 15, 2018 updated by: Robert K Cleary, Saint Joseph Mercy Health System

A Prospective Randomized Clinical Trial Comparing the Transversus Abdominis Plane Block (TAP) Versus Epidural Anesthesia For Enhanced Recovery Pathway Perioperative Management of Pain in Elective Colorectal Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.

This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl;
  • Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP Block- Exparel
Transversus abdominis plane block utilizing the medication Exparel®
Procedure: TAP Block
This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
Other Names:
  • Exparel
Active Comparator: Continuous Epidural Analgesia
Procedure: Continuous Epidural Analgesia
Epidural catheter placed prior to the operation in the standard fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain control day 1 using the numeric pain scale
Time Frame: Post-operative day 1
Measured by patient using the numeric pain scale
Post-operative day 1
Post-operative pain control day 2 using the numeric pain scale
Time Frame: Post-operative day 2
Measured by patient using the numeric pain scale
Post-operative day 2
Post-operative pain control day 3 using the numeric pain scale
Time Frame: Post-operative day 3
Measured by patient using the numeric pain scale
Post-operative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall benefits of analgesia treatment post-operative day 1
Time Frame: Post-operative day 1
Measured by patient completing the Overall Benefits of Analgesia Score survey
Post-operative day 1
Overall benefits of analgesia treatment post-operative day 2
Time Frame: Post-operative day 2
Measured by patient completing the Overall Benefits of Analgesia Score survey
Post-operative day 2
Overall benefits of analgesia treatment post-operative day 3
Time Frame: Post-operative day 3
Measured by patient completing the Overall Benefits of Analgesia Score survey
Post-operative day 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient use of supplemental narcotic analgesia post-operative day 1
Time Frame: Post-operative day 1
Measured in morphine equivalents
Post-operative day 1
Patient use of supplemental narcotic analgesia post-operative day 2
Time Frame: Post-operative day 2
Measured in morphine equivalents
Post-operative day 2
Patient use of supplemental narcotic analgesia post-operative day 3
Time Frame: Post-operative day 3
Measured in morphine equivalents
Post-operative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Joseph Mercy Health System

Investigators

  • Principal Investigator: Robert K Cleary, MD, Saint Joseph Mercy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR 15-1618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on TAP Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe