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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 Soaker™ 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 Short Form (SF)- 36 questionnaire
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Start Date
January 1, 2010
Primary Completion Date
March 1, 2015
Completion Date
March 1, 2015
Last Updated
September 15, 2025
98
ACTUAL participants
Continuous Preperitoneal Analgesia
DEVICE
Continuous Epidural Analgesia
DEVICE
Lead Sponsor
Trinity Health Michigan
NCT04929028
NCT04704661
Data Source & Attribution
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