search
Back to results

Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Primary Purpose

Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Preperitoneal Analgesia
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

Eligibility Criteria

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

Inclusion Criteria:

  • Age > = 18 years
  • Scheduled for elective colon or rectal surgery
  • Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
  • Able to provide informed consent
  • Able to complete patient questionnaire

Exclusion Criteria:

  • Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
  • Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
  • Urgent surgery precluding epidural catheter placement
  • Systemic Infection contraindicating epidural catheter placement
  • Unwillingness to participate in follow up assessments
  • Prisoners

Sites / Locations

  • Saint Joseph Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous Preperitoneal Analgesia

Continuous Epidural Analgesia

Arm Description

Continuous Preperitoneal Analgesia for pain management

Continuous Epidural Analgesia for pain management

Outcomes

Primary Outcome Measures

Post-operative pain control day 1
Measured by the patient using the numerical pain scale.
Post-operative pain control day 2
Measured by patient using the numerical pain scale.
Post-operative pain control day 3
Measured by patient using the numerical pain scale.
Post-operative pain control day 4
Measured by patient using the numerical pain scale.
Post-operative pain control day 5
Measured by patient using the numerical pain scale.

Secondary Outcome Measures

Patient use of supplemental narcotic analgesia day 1
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 2
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 3
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 4
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 5
Measured in morphine equivalents

Full Information

First Posted
February 28, 2012
Last Updated
July 22, 2014
Sponsor
Saint Joseph Mercy Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT01552226
Brief Title
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Official Title
Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).
Detailed Description
Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters. Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use. Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage. Other variables of interest Surgical site infections The post-operative time to return of bowel function The hospital expenses/cost differences Quality of life measured with the SF- 36 questionnaire

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Continuous Preperitoneal Analgesia
Arm Type
Active Comparator
Arm Description
Continuous Preperitoneal Analgesia for pain management
Arm Title
Continuous Epidural Analgesia
Arm Type
Active Comparator
Arm Description
Continuous Epidural Analgesia for pain management
Intervention Type
Device
Intervention Name(s)
Continuous Preperitoneal Analgesia
Other Intervention Name(s)
On-Q Silver Soaker(tm)
Intervention Description
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
Intervention Type
Device
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
Description
Measured by the patient using the numerical pain scale.
Time Frame
Post-operative day 1
Title
Post-operative pain control day 2
Description
Measured by patient using the numerical pain scale.
Time Frame
Post-operative day 2
Title
Post-operative pain control day 3
Description
Measured by patient using the numerical pain scale.
Time Frame
Post-operative day 3
Title
Post-operative pain control day 4
Description
Measured by patient using the numerical pain scale.
Time Frame
Post-operative day 4
Title
Post-operative pain control day 5
Description
Measured by patient using the numerical pain scale.
Time Frame
Post-operative day 5
Secondary Outcome Measure Information:
Title
Patient use of supplemental narcotic analgesia day 1
Description
Measured in morphine equivalents
Time Frame
Post-operative day 1
Title
Patient use of supplemental narcotic analgesia day 2
Description
Measured in morphine equivalents
Time Frame
Post-operative day 2
Title
Patient use of supplemental narcotic analgesia day 3
Description
Measured in morphine equivalents
Time Frame
Post-operative day 3
Title
Patient use of supplemental narcotic analgesia day 4
Description
Measured in morphine equivalents
Time Frame
Post-operative day 4
Title
Patient use of supplemental narcotic analgesia day 5
Description
Measured in morphine equivalents
Time Frame
Post-operative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > = 18 years Scheduled for elective colon or rectal surgery Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic) Able to provide informed consent Able to complete patient questionnaire Exclusion Criteria: Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc) Urgent surgery precluding epidural catheter placement Systemic Infection contraindicating epidural catheter placement Unwillingness to participate in follow up assessments Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Cleary, MD
Organizational Affiliation
Saint Joseph Mercy Health System
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

Links:
URL
http://www.fascrs.org
Description
American Society of Colon and Rectal Surgeons

Learn more about this trial

Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery

We'll reach out to this number within 24 hrs