Clinical trial NCT01552226: Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Official title: Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Colonic Diverticulosis
Lead sponsor: Saint Joseph Mercy Health System
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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 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

Primary outcomes:
measure: Post-operative pain control day 1
timeFrame: Post-operative day 1
measure: Post-operative pain control day 2
timeFrame: Post-operative day 2
measure: Post-operative pain control day 3
timeFrame: Post-operative day 3
measure: Post-operative pain control day 4
timeFrame: Post-operative day 4
measure: Post-operative pain control day 5
timeFrame: Post-operative day 5
Secondary outcomes:
measure: Patient use of supplemental narcotic analgesia day 1
timeFrame: Post-operative day 1
measure: Patient use of supplemental narcotic analgesia day 2
timeFrame: Post-operative day 2
measure: Patient use of supplemental narcotic analgesia day 3
timeFrame: Post-operative day 3
measure: Patient use of supplemental narcotic analgesia day 4
timeFrame: Post-operative day 4
measure: Patient use of supplemental narcotic analgesia day 5
timeFrame: Post-operative day 5
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
Study officials:
affiliation: Saint Joseph Mercy Health System
name: Robert Cleary, MD
role: PRINCIPAL_INVESTIGATOR
References: