A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
Status unconfirmed · Phase 4
Conditions studied: Analgesia, Post-Operative Pain, Breakthrough Pain, Colectomy
In brief
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.
Key facts
- Study ID
- NCT05200806
- Run by
- University of Vermont
- People needed
- 25
- Starts
- 2022-02-07
- Expected to finish
- 2024-10-01
- Last updated by the study team
- 2022-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- UVM Medical Center — Burlington, Vermont, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.