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
About this trial
This is an interventional supportive care trial for Colon Cancer
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
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
NCT ID
NCT01552226
First Posted
February 28, 2012
Last Updated
July 22, 2014
Sponsor
Saint Joseph Mercy Health System
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
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