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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Saint Joseph Mercy Health System.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552226
First Posted: March 13, 2012
Last Update Posted: July 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
  Purpose
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).

Condition Intervention
Colon Cancer Rectal Cancer Colonic Diverticulosis Device: Continuous Preperitoneal Analgesia Device: Continuous Epidural Analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Further study details as provided by Saint Joseph Mercy Health System:

Primary Outcome Measures:
  • Post-operative pain control day 1 [ Time Frame: Post-operative day 1 ]
    Measured by the patient using the numerical pain scale.

  • Post-operative pain control day 2 [ Time Frame: Post-operative day 2 ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 3 [ Time Frame: Post-operative day 3 ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 4 [ Time Frame: Post-operative day 4 ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 5 [ Time Frame: Post-operative day 5 ]
    Measured by patient using the numerical pain scale.


Secondary Outcome Measures:
  • Patient use of supplemental narcotic analgesia day 1 [ Time Frame: Post-operative day 1 ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 2 [ Time Frame: Post-operative day 2 ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 3 [ Time Frame: Post-operative day 3 ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 4 [ Time Frame: Post-operative day 4 ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 5 [ Time Frame: Post-operative day 5 ]
    Measured in morphine equivalents


Estimated Enrollment: 137
Study Start Date: January 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552226


Locations
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Robert Cleary, MD Saint Joseph Mercy Health System
  More Information

Additional Information:
Responsible Party: Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT01552226     History of Changes
Other Study ID Numbers: RCNM 114
First Submitted: February 28, 2012
First Posted: March 13, 2012
Last Update Posted: July 23, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Diverticulum
Diverticulosis, Colonic
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases