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

Study Overview
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Brief Summary
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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
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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

Official Title
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Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Conditions
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Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Intervention / Treatment
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* Device: Continuous Preperitoneal Analgesia
* Device: Continuous Epidural Analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Preperitoneal Analgesia<br>Continuous Preperitoneal Analgesia for pain management | Device: Continuous Preperitoneal Analgesia<br>* Preperitoneal catheter placed at the completion of surgery in the standard fashion.<br>* Other names: On-Q Silver Soaker(tm);|
| Active Comparator: Continuous Epidural Analgesia<br>Continuous Epidural Analgesia for pain management | Device: Continuous Epidural Analgesia<br>* Epidural catheter placed prior to the operation in the standard fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain control day 1 | Measured by the patient using the numerical pain scale. | Post-operative day 1 | 
| Post-operative pain control day 2 | Measured by patient using the numerical pain scale. | Post-operative day 2 | 
| Post-operative pain control day 3 | Measured by patient using the numerical pain scale. | Post-operative day 3 | 
| Post-operative pain control day 4 | Measured by patient using the numerical pain scale. | Post-operative day 4 | 
| Post-operative pain control day 5 | Measured by patient using the numerical pain scale. | Post-operative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient use of supplemental narcotic analgesia day 1 | Measured in morphine equivalents | Post-operative day 1 | 
| Patient use of supplemental narcotic analgesia day 2 | Measured in morphine equivalents | Post-operative day 2 | 
| Patient use of supplemental narcotic analgesia day 3 | Measured in morphine equivalents | Post-operative day 3 | 
| Patient use of supplemental narcotic analgesia day 4 | Measured in morphine equivalents | Post-operative day 4 | 
| Patient use of supplemental narcotic analgesia day 5 | Measured in morphine equivalents | Post-operative day 5 |