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

NCT ID: NCT01552226

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-03-31

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 Soaker™ 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 Short Form (SF)- 36 questionnaire

Conditions

Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Continuous Preperitoneal Analgesia (CPA)

Continuous Preperitoneal Analgesia for pain management

Group Type: ACTIVE_COMPARATOR

Continuous Preperitoneal Analgesia

Intervention Type: DEVICE

Preperitoneal catheter placed at the completion of surgery in the standard fashion.

Continuous Epidural Analgesia (CEA)

Continuous Epidural Analgesia for pain management

Group Type: ACTIVE_COMPARATOR

Continuous Epidural Analgesia

Intervention Type: DEVICE

Epidural catheter placed prior to the operation in the standard fashion.

Interventions

Continuous Preperitoneal Analgesia

Preperitoneal catheter placed at the completion of surgery in the standard fashion.

Intervention Type: DEVICE

Continuous Epidural Analgesia

Epidural catheter placed prior to the operation in the standard fashion.

Intervention Type: DEVICE

Other Intervention Names

On-Q Silver Soaker(tm)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trinity Health Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Cleary, MD

Role: PRINCIPAL_INVESTIGATOR

Trinity Health Michigan

Locations

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Countries

United States

Related Links

http://www.fascrs.org

American Society of Colon and Rectal Surgeons

Other Identifiers

RCNM 114

Identifier Type: -

Identifier Source: org_study_id