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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

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

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).

Detailed Summary:

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

Sponsor: Saint Joseph Mercy Health System

Current Primary Outcome:

• Post-operative pain control day 1 [ Time Frame: Post-operative day 1 ]
  Measured by the patient using the numerical pain scale.
• Post-operative pain control day 2 [ Time Frame: Post-operative day 2 ]
  Measured by patient using the numerical pain scale.
• Post-operative pain control day 3 [ Time Frame: Post-operative day 3 ]
  Measured by patient using the numerical pain scale.
• Post-operative pain control day 4 [ Time Frame: Post-operative day 4 ]
  Measured by patient using the numerical pain scale.
• Post-operative pain control day 5 [ Time Frame: Post-operative day 5 ]
  Measured by patient using the numerical pain scale.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Patient use of supplemental narcotic analgesia day 1 [ Time Frame: Post-operative day 1 ]
  Measured in morphine equivalents
• Patient use of supplemental narcotic analgesia day 2 [ Time Frame: Post-operative day 2 ]
  Measured in morphine equivalents
• Patient use of supplemental narcotic analgesia day 3 [ Time Frame: Post-operative day 3 ]
  Measured in morphine equivalents
• Patient use of supplemental narcotic analgesia day 4 [ Time Frame: Post-operative day 4 ]
  Measured in morphine equivalents
• Patient use of supplemental narcotic analgesia day 5 [ Time Frame: Post-operative day 5 ]
  Measured in morphine equivalents

Original Secondary Outcome: Same as current

Information By: Saint Joseph Mercy Health System

Dates:
Date Received: February 28, 2012
Date Started: January 2010
Date Completion: March 2015
Last Updated: July 22, 2014
Last Verified: July 2014