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

NCT01552226 | Completed Results

• 1 other identifier: RCNM 114
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Patient Use of Supplemental Narcotic Analgesia Day 1

  Post-operative day 1

• Patient Use of Supplemental Narcotic Analgesia Day 2

  Post-operative day 2

• Patient Use of Supplemental Narcotic Analgesia Day 3

  Post-operative day 3

• Patient Use of Supplemental Narcotic Analgesia Day 4

  Post-operative day 4

• Patient Use of Supplemental Narcotic Analgesia Day 0

  Post-operative day 0

Study Arms (2)

Continuous Preperitoneal Analgesia (CPA)

ACTIVE COMPARATOR

Continuous Preperitoneal Analgesia for pain management

Device: Continuous Preperitoneal Analgesia

Continuous Epidural Analgesia (CEA)

ACTIVE COMPARATOR

Continuous Epidural Analgesia for pain management

Device: Continuous Epidural Analgesia

Interventions

Continuous Preperitoneal Analgesia DEVICE

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

Also known as: On-Q Silver Soaker(tm)

Continuous Preperitoneal Analgesia (CPA)

Continuous Epidural Analgesia DEVICE

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

Continuous Epidural Analgesia (CEA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trinity Health Michigan: lead

Study Sites (1)

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Related Links

• American Society of Colon and Rectal Surgeons

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Robert Cleary
• Organization: St. Joseph Mercy Hospital Ann Arbor

Robert.Cleary@trinity-health.org

7347128150

Study Officials

• Robert Cleary, MD

  Trinity Health Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 13, 2012
• Study Start: January 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

US (1)