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

NCT05200806 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • Analgesia
  • Post-Operative Pain
  • Breakthrough Pain
  • Colectomy

Interventions

OTHER

Non-Narcotic ERAS Post-Operative Pain Management

As described previously.

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Principal Investigators

  • Peter Cataldo, MD · University of Vermont Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2023-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200806 on ClinicalTrials.gov