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

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).

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Colon Cancer; Colonic Diverticulosis
• Intervention / Treatment: Device: Continuous Preperitoneal Analgesia; Device: Continuous Epidural Analgesia

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

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Preperitoneal Analgesia (CPA); Continuous Preperitoneal Analgesia for pain management	Device: Continuous Preperitoneal Analgesia; Preperitoneal catheter placed at the completion of surgery in the standard fashion.; Other Names: On-Q Silver Soaker(tm)
Active Comparator: Continuous Epidural Analgesia (CEA); Continuous Epidural Analgesia for pain management	Device: Continuous Epidural Analgesia; Epidural catheter placed prior to the operation in the standard fashion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Numerical Pain Score-Day 0	Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	Post-operative day 0
Postoperative Numerical Pain Score-Day 1	Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	Post-operative day 1
Postoperative Numerical Pain Score-Day 2	Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	Post-operative day 2
Postoperative Numerical Pain Score-Day 3	Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	Post-operative day 3
Postoperative Numerical Pain Score-Day 4	Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	Post-operative day 4
Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)	Postoperative NPS is a pain screening tool, commonly used to assess the pain severity a patient experiences after surgery, where "0" indicates no pain and "10" represents the worst pain imaginable".	After surgery in the post-anesthesia care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Use of Supplemental Narcotic Analgesia Day 1	Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents.	Post-operative day 1
Patient Use of Supplemental Narcotic Analgesia Day 2	Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents.	Post-operative day 2
Patient Use of Supplemental Narcotic Analgesia Day 3	Patient use of supplemental narcotic analgesia on day 3, measured in morphine equivalents.	Post-operative day 3
Patient Use of Supplemental Narcotic Analgesia Day 4	Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents.	Post-operative day 4
Patient Use of Supplemental Narcotic Analgesia Day 0	Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents.	Post-operative day 0

Collaborators and Investigators

• Sponsor: Trinity Health Michigan
• Investigators: Principal Investigator: Robert Cleary, MD, Trinity Health Michigan

Publications and helpful links

Helpful Links

• American Society of Colon and Rectal Surgeons

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimated): March 13, 2012

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colonic Neoplasms; Diverticulosis, Colonic
• Other Study ID Numbers: RCNM 114