UnknownPhase 4Other

A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy

Sponsored by University of Vermont

NCT ID
NCT05200806
Target Enrollment
25 participants
Start Date
2022-02-07
Est. Completion
2024-10

About This Study

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.

Conditions Studied

AnalgesiaPost-Operative PainBreakthrough PainColectomy

Interventions

  • Non-Narcotic ERAS Post-Operative Pain Management

Eligibility

Age:18 Years - N/A
Healthy Volunteers:Yes
View full eligibility criteria
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

Study Locations (1)

UVM Medical Center
Burlington, Vermont, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source