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

This study is currently recruiting participants.
Verified March 2012 by Saint Joseph Mercy Health System
Sponsor:
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01552226
First received: February 28, 2012
Last updated: March 8, 2012
Last verified: March 2012

February 28, 2012
March 8, 2012
January 2010
January 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01552226 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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 SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Colon Cancer
  • Rectal Cancer
  • Colonic Diverticulosis
  • Device: Continuous Preperitoneal Analgesia
    Preperitoneal catheter placed at the completion of surgery in the standard fashion.
    Other Name: On-Q Silver Soaker(tm)
  • Device: Continuous Epidural Analgesia
    Epidural catheter placed prior to the operation in the standard fashion.
  • Active Comparator: Continuous Preperitoneal Analgesia
    Continuous Preperitoneal Analgesia for pain management
    Intervention: Device: Continuous Preperitoneal Analgesia
  • Active Comparator: Continuous Epidural Analgesia
    Continuous Epidural Analgesia for pain management
    Intervention: Device: Continuous Epidural Analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
137
June 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robert K Cleary, MD 734-712-8150 clearyrk@trinity-health.org
Contact: Felicia A Formosa, BS 734-712-5396 formosaf@trinity-health.org
United States
 
NCT01552226
RCNM 114
No
Saint Joseph Mercy Health System
Saint Joseph Mercy Health System
Not Provided
Principal Investigator: Robert Cleary, MD Saint Joseph Mercy Health System
Saint Joseph Mercy Health System
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP