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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:January 2010
End Date:June 2014
Contact:Robert K Cleary, MD
Email:clearyrk@trinity-health.org
Phone:734-712-8150

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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

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).

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

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
We found this trial at
1
site
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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mi
from
Ann Arbor, MI
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