Colon Cancer Clinical Trial

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

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).

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Full 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

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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

Study is for people with:

Colon Cancer

Estimated Enrollment:

137

Study ID:

NCT01552226

Recruitment Status:

Unknown status

Sponsor:

Saint Joseph Mercy Health System

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There is 1 Location for this study

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Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

137

Study ID:

NCT01552226

Recruitment Status:

Unknown status

Sponsor:


Saint Joseph Mercy Health System

How clear is this clinincal trial information?

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