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

Rectal Cancer Clinical Trial

Official title:

Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01552226
• Other study ID #: RCNM 114
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2012
• Last updated: July 22, 2014
• Start date: January 2010
• Est. completion date: March 2015

Study information

• Verified date: July 2014
• Source: Saint Joseph Mercy Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Diverticulosis
• Diverticulosis, Colonic
• Diverticulum
• Rectal Cancer

Intervention

Device:
• Continuous Preperitoneal Analgesia
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
• Continuous Epidural Analgesia
Epidural catheter placed prior to the operation in the standard fashion.

Locations

Country	Name	City	State
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Saint Joseph Mercy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain control day 1	Measured by the patient using the numerical pain scale.	Post-operative day 1	No
Primary	Post-operative pain control day 2	Measured by patient using the numerical pain scale.	Post-operative day 2	No
Primary	Post-operative pain control day 3	Measured by patient using the numerical pain scale.	Post-operative day 3	No
Primary	Post-operative pain control day 4	Measured by patient using the numerical pain scale.	Post-operative day 4	No
Primary	Post-operative pain control day 5	Measured by patient using the numerical pain scale.	Post-operative day 5	No
Secondary	Patient use of supplemental narcotic analgesia day 1	Measured in morphine equivalents	Post-operative day 1	No
Secondary	Patient use of supplemental narcotic analgesia day 2	Measured in morphine equivalents	Post-operative day 2	No
Secondary	Patient use of supplemental narcotic analgesia day 3	Measured in morphine equivalents	Post-operative day 3	No
Secondary	Patient use of supplemental narcotic analgesia day 4	Measured in morphine equivalents	Post-operative day 4	No
Secondary	Patient use of supplemental narcotic analgesia day 5	Measured in morphine equivalents	Post-operative day 5	No

External Links

•   American Society of Colon and Rectal Surgeons