CompletedNot Applicable

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

United States98 participantsStarted 2010-01

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Numerical Pain Score-Day 0

Timeframe: Post-operative day 0

Postoperative Numerical Pain Score-Day 1

Timeframe: Post-operative day 1

Postoperative Numerical Pain Score-Day 2

Timeframe: Post-operative day 2

Postoperative Numerical Pain Score-Day 3

Timeframe: Post-operative day 3

Postoperative Numerical Pain Score-Day 4

Timeframe: Post-operative day 4

Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)

Timeframe: After surgery in the post-anesthesia care unit

Trial details

NCT IDNCT01552226

SponsorTrinity Health Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2025-01-09

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