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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal Cancer, Colonic Diverticulosis

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Post-operative pain control day 1

Outcome Description:

Measured by the patient using the numerical pain scale.

Outcome Time Frame:

Post-operative day 1

Safety Issue:

No

Principal Investigator

Robert Cleary, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Joseph Mercy Health System

Authority:

United States: Institutional Review Board

Study ID:

RCNM 114

NCT ID:

NCT01552226

Start Date:

January 2010

Completion Date:

June 2014

Related Keywords:

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

Name

Location

Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106