A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy (NCT05200806) | Clinical Trial Compass
UnknownPhase 4
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
United States25 participantsStarted 2022-02-07
Plain-language summary
With this pilot investigation, the investigators aim to challenge the reliance on opiate analgesia following colon and rectal surgery. Narcotic misuse and abuse is a pressing public health concern, and reduction in prescription rates could help to mitigate this issue. The goal of this pilot study is to establish feasibility of sufficient post-operative pain control after colectomy using non-narcotic analgesics. The investigators hypothesize that patients will be able to manage their post-operative pain without narcotic intervention, while minimizing side effects and complications. This initial pilot study will provide proof-of-concept for a larger, randomized investigation on non-narcotic analgesia after colectomy.
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:
* ≥ 18 years of age
* Undergoing elective abdominal colectomy
* Eligible for the Enhanced Recovery After Surgery (ERAS) protocol currently in place for colectomy patients at UVMMC
Exclusion Criteria:
* allergy to any protocol medication
* emergent or urgent bowel surgery
* pre-operative plan for a stoma
* pre-operative diagnosis of rectal cancer (pre-operative diagnosis of rectosigmoid cancer is not necessarily excluded)
* neoadjuvant chemoradiation
* additional malignant disease outside of the colon
* narcotic usage within the three months of scheduled operation date, for more than one week
* chronic pain
* pain score \>2 at the initial evaluation for study inclusion
* dementia
Note: Eligibility will be determined by the research coordinator and approved by the surgeon
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
1
Failure Rate
Timeframe: Until post-op clinic visit (estimated 3-4 weeks post-op)