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

July 22, 2014 updated by: Saint Joseph Mercy Health System

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 SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Preperitoneal Analgesia
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
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
Post-operative pain control day 1
Time Frame: Post-operative day 1
Measured by the patient using the numerical pain scale.
Post-operative day 1
Post-operative pain control day 2
Time Frame: Post-operative day 2
Measured by patient using the numerical pain scale.
Post-operative day 2
Post-operative pain control day 3
Time Frame: Post-operative day 3
Measured by patient using the numerical pain scale.
Post-operative day 3
Post-operative pain control day 4
Time Frame: Post-operative day 4
Measured by patient using the numerical pain scale.
Post-operative day 4
Post-operative pain control day 5
Time Frame: Post-operative day 5
Measured by patient using the numerical pain scale.
Post-operative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient use of supplemental narcotic analgesia day 1
Time Frame: Post-operative day 1
Measured in morphine equivalents
Post-operative day 1
Patient use of supplemental narcotic analgesia day 2
Time Frame: Post-operative day 2
Measured in morphine equivalents
Post-operative day 2
Patient use of supplemental narcotic analgesia day 3
Time Frame: Post-operative day 3
Measured in morphine equivalents
Post-operative day 3
Patient use of supplemental narcotic analgesia day 4
Time Frame: Post-operative day 4
Measured in morphine equivalents
Post-operative day 4
Patient use of supplemental narcotic analgesia day 5
Time Frame: Post-operative day 5
Measured in morphine equivalents
Post-operative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Joseph Mercy Health System

Investigators

  • Principal Investigator: Robert Cleary, MD, Saint Joseph Mercy Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCNM 114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Continuous Preperitoneal Analgesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe