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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01552226
First received: February 28, 2012
Last updated: July 22, 2014
Last verified: July 2014
  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: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    Measured by the patient using the numerical pain scale.

  • Post-operative pain control day 2 [ Time Frame: Post-operative day 2 ] [ Designated as safety issue: No ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 3 [ Time Frame: Post-operative day 3 ] [ Designated as safety issue: No ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 4 [ Time Frame: Post-operative day 4 ] [ Designated as safety issue: No ]
    Measured by patient using the numerical pain scale.

  • Post-operative pain control day 5 [ Time Frame: Post-operative day 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 2 [ Time Frame: Post-operative day 2 ] [ Designated as safety issue: No ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 3 [ Time Frame: Post-operative day 3 ] [ Designated as safety issue: No ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 4 [ Time Frame: Post-operative day 4 ] [ Designated as safety issue: No ]
    Measured in morphine equivalents

  • Patient use of supplemental narcotic analgesia day 5 [ Time Frame: Post-operative day 5 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT01552226     History of Changes
Other Study ID Numbers: RCNM 114
Study First Received: February 28, 2012
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Diverticulum
Diverticulosis, Colonic
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014