Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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Surgical site infections
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The post-operative time to return of bowel function
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The hospital expenses/cost differences
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Quality of life measured with the SF- 36 questionnaire
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Continuous Preperitoneal Analgesia Continuous Preperitoneal Analgesia for pain management |
Device: Continuous Preperitoneal Analgesia
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
Other Names:
|
| Active Comparator: Continuous Epidural Analgesia Continuous Epidural Analgesia for pain management |
Device: Continuous Epidural Analgesia
Epidural catheter placed prior to the operation in the standard fashion.
|
Outcome Measures
Primary Outcome Measures
- Post-operative pain control day 1 [Post-operative day 1]
Measured by the patient using the numerical pain scale.
- Post-operative pain control day 2 [Post-operative day 2]
Measured by patient using the numerical pain scale.
- Post-operative pain control day 3 [Post-operative day 3]
Measured by patient using the numerical pain scale.
- Post-operative pain control day 4 [Post-operative day 4]
Measured by patient using the numerical pain scale.
- Post-operative pain control day 5 [Post-operative day 5]
Measured by patient using the numerical pain scale.
Secondary Outcome Measures
- Patient use of supplemental narcotic analgesia day 1 [Post-operative day 1]
Measured in morphine equivalents
- Patient use of supplemental narcotic analgesia day 2 [Post-operative day 2]
Measured in morphine equivalents
- Patient use of supplemental narcotic analgesia day 3 [Post-operative day 3]
Measured in morphine equivalents
- Patient use of supplemental narcotic analgesia day 4 [Post-operative day 4]
Measured in morphine equivalents
- Patient use of supplemental narcotic analgesia day 5 [Post-operative day 5]
Measured in morphine equivalents
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > = 18 years
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Scheduled for elective colon or rectal surgery
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Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
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Able to provide informed consent
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Able to complete patient questionnaire
Exclusion Criteria:
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Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
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Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
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Urgent surgery precluding epidural catheter placement
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Systemic Infection contraindicating epidural catheter placement
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Unwillingness to participate in follow up assessments
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
Sponsors and Collaborators
- Saint Joseph Mercy Health System
Investigators
- Principal Investigator: Robert Cleary, MD, Saint Joseph Mercy Health System
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- RCNM 114