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

Trinity Health Michigan

Status: Completed

Conditions: Colonic Diverticulosis; Colon Cancer; Rectal Cancer

Treatments: Device: Continuous Epidural Analgesia; Device: Continuous Preperitoneal Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01552226

RCNM 114

Details and patient eligibility

About

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

Full 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 Short Form (SF)- 36 questionnaire

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Continuous Preperitoneal Analgesia (CPA)

Active Comparator group

Description:

Continuous Preperitoneal Analgesia for pain management

Treatment:

Device: Continuous Preperitoneal Analgesia

Continuous Epidural Analgesia (CEA)

Active Comparator group

Description:

Continuous Epidural Analgesia for pain management

Treatment:

Device: Continuous Epidural Analgesia