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

Primary Purpose

Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP Block
Continuous Epidural Analgesia
Sponsored by
Saint Joseph Mercy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring Continuous Epidural Analgesia, Transversus Abdominis Plane block

Eligibility Criteria

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

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

Sites / Locations

  • Saint Joseph Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block- Exparel

Continuous Epidural Analgesia

Arm Description

Transversus abdominis plane block utilizing the medication Exparel®

Continuous Epidural Analgesia

Outcomes

Primary Outcome Measures

Post-operative pain control day 1 using the numeric pain scale
Measured by patient using the numeric pain scale
Post-operative pain control day 2 using the numeric pain scale
Measured by patient using the numeric pain scale
Post-operative pain control day 3 using the numeric pain scale
Measured by patient using the numeric pain scale

Secondary Outcome Measures

Overall benefits of analgesia treatment post-operative day 1
Measured by patient completing the Overall Benefits of Analgesia Score survey
Overall benefits of analgesia treatment post-operative day 2
Measured by patient completing the Overall Benefits of Analgesia Score survey
Overall benefits of analgesia treatment post-operative day 3
Measured by patient completing the Overall Benefits of Analgesia Score survey

Full Information

First Posted
October 7, 2015
Last Updated
May 15, 2018
Sponsor
Saint Joseph Mercy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02591407
Brief Title
Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery
Acronym
TAP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Joseph Mercy Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Keywords
Continuous Epidural Analgesia, Transversus Abdominis Plane block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block- Exparel
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block utilizing the medication Exparel®
Arm Title
Continuous Epidural Analgesia
Arm Type
Active Comparator
Arm Description
Continuous Epidural Analgesia
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Other Intervention Name(s)
Exparel
Intervention Description
This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
Intervention Type
Procedure
Intervention Name(s)
Continuous Epidural Analgesia
Intervention Description
Epidural catheter placed prior to the operation in the standard fashion
Primary Outcome Measure Information:
Title
Post-operative pain control day 1 using the numeric pain scale
Description
Measured by patient using the numeric pain scale
Time Frame
Post-operative day 1
Title
Post-operative pain control day 2 using the numeric pain scale
Description
Measured by patient using the numeric pain scale
Time Frame
Post-operative day 2
Title
Post-operative pain control day 3 using the numeric pain scale
Description
Measured by patient using the numeric pain scale
Time Frame
Post-operative day 3
Secondary Outcome Measure Information:
Title
Overall benefits of analgesia treatment post-operative day 1
Description
Measured by patient completing the Overall Benefits of Analgesia Score survey
Time Frame
Post-operative day 1
Title
Overall benefits of analgesia treatment post-operative day 2
Description
Measured by patient completing the Overall Benefits of Analgesia Score survey
Time Frame
Post-operative day 2
Title
Overall benefits of analgesia treatment post-operative day 3
Description
Measured by patient completing the Overall Benefits of Analgesia Score survey
Time Frame
Post-operative day 3
Other Pre-specified Outcome Measures:
Title
Patient use of supplemental narcotic analgesia post-operative day 1
Description
Measured in morphine equivalents
Time Frame
Post-operative day 1
Title
Patient use of supplemental narcotic analgesia post-operative day 2
Description
Measured in morphine equivalents
Time Frame
Post-operative day 2
Title
Patient use of supplemental narcotic analgesia post-operative day 3
Description
Measured in morphine equivalents
Time Frame
Post-operative day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert K Cleary, MD
Organizational Affiliation
Saint Joseph Mercy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30192328
Citation
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.
Results Reference
derived
Links:
URL
http://www.fascrs.org
Description
American Society of Colon and Rectal Surgeons

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

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