Overview

This trial is active, not recruiting.

Conditions colon cancer, rectal cancer, colonic diverticulosis
Treatments continuous preperitoneal analgesia, continuous epidural analgesia
Sponsor Saint Joseph Mercy Health System
Start date January 2010
End date March 2015
Trial size 137 participants
Trial identifier NCT01552226, RCNM 114

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Continuous Preperitoneal Analgesia for pain management
continuous preperitoneal analgesia On-Q Silver Soaker(tm)
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
(Active Comparator)
Continuous Epidural Analgesia for pain management
continuous epidural analgesia
Epidural catheter placed prior to the operation in the standard fashion.

Primary Outcomes

Measure
Post-operative pain control day 1
time frame: Post-operative day 1
Post-operative pain control day 2
time frame: Post-operative day 2
Post-operative pain control day 3
time frame: Post-operative day 3
Post-operative pain control day 4
time frame: Post-operative day 4
Post-operative pain control day 5
time frame: Post-operative day 5

Secondary Outcomes

Measure
Patient use of supplemental narcotic analgesia day 1
time frame: Post-operative day 1
Patient use of supplemental narcotic analgesia day 2
time frame: Post-operative day 2
Patient use of supplemental narcotic analgesia day 3
time frame: Post-operative day 3
Patient use of supplemental narcotic analgesia day 4
time frame: Post-operative day 4
Patient use of supplemental narcotic analgesia day 5
time frame: Post-operative day 5

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Principal investigator Robert Cleary, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Saint Joseph Mercy Health System.