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

Not Applicable

• Conditions: Colonic Diverticulosis; Colon Cancer; Rectal Cancer
• Interventions: Device: Continuous Preperitoneal Analgesia; Device: Continuous Epidural Analgesia

• Registration Number: NCT01552226
• Lead Sponsor: Saint Joseph Mercy Health System

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 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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Preperitoneal Analgesia	Continuous Preperitoneal Analgesia	Continuous Preperitoneal Analgesia for pain management
Continuous Epidural Analgesia	Continuous Epidural Analgesia	Continuous Epidural Analgesia for pain management

Primary Outcome Measures

Name	Time	Method
Post-operative pain control day 1	Post-operative day 1	Measured by the patient using the numerical pain scale.
Post-operative pain control day 2	Post-operative day 2	Measured by patient using the numerical pain scale.
Post-operative pain control day 3	Post-operative day 3	Measured by patient using the numerical pain scale.
Post-operative pain control day 4	Post-operative day 4	Measured by patient using the numerical pain scale.
Post-operative pain control day 5	Post-operative day 5	Measured by patient using the numerical pain scale.

Secondary Outcome Measures

Name	Time	Method
Patient use of supplemental narcotic analgesia day 1	Post-operative day 1	Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 2	Post-operative day 2	Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 3	Post-operative day 3	Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 4	Post-operative day 4	Measured in morphine equivalents
Patient use of supplemental narcotic analgesia day 5	Post-operative day 5	Measured in morphine equivalents

Trial Locations

Locations (1)

Saint Joseph Mercy Hospital; 🇺🇸 Ann Arbor, Michigan, United States