Status:
UNKNOWN
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
Lead Sponsor:
University of Vermont
Conditions:
Analgesia
Post-Operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, an...
Detailed Description
Our primary objectives are: * Determine the rate of patients needing rescue narcotics prescriptions for breakthrough postoperative pain after colectomy while on a non-narcotic postoperative protocol....
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05200806
Start Date
February 7 2022
End Date
October 1 2024
Last Update
October 14 2022
Active Locations (1)
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1
UVM Medical Center
Burlington, Vermont, United States, 05405