Recruiting

Non-Narcotic Course

Sponsor:

University of Vermont

Code:

NCT05200806

Conditions

Analgesia

Post-Operative Pain

Breakthrough Pain

Colectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Narcotic ERAS Post-Operative Pain Management

Study Details

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, 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

Study ID

NCT05200806

Start date

Feb 7, 2022

Status verified date

Oct, 2022

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention

Pre-Op Enhanced Recovery After Surgery (ERAS): Gabapentin (900mg capsule), Acetaminophen (1,000mg tablet), Dexamethasone (8mg IV), Granisetron (1mg IV), Morphine (0.15mg Intrathecal) Intraoperatively: Appropriate medications administered at discretion of the treating anesthesiologist during colectomy, with Ketamine use encouraged if not contraindicated. Post-Op (PACU, Onward during inpatient stay): Acetaminophen (Oral) (650mg, q4hrs), Gabapentin (300mg, q6hours), Methocarbamol (750mg, QID), 5% Lidocaine Patch (q12hrs PRN) One time rescue dose (Hydromorphone, Morphine, Oxycodone) available for breakthrough pain during hospital stay (differs from traditional ERAS protocol where medications can be administered as needed). If one-time rescue dose is needed, the covering physician will be notified and can choose to order an appropriate narcotic regimen for remainder of patient's hospitalization. All patients are discharged with a narcotics prescription that they can choose to fill.

Interventions

Non-Narcotic ERAS Post-Operative Pain Management

As described previously.

Primary outcome measure

  • Failure Rate [ Time Frame: Until post-op clinic visit (estimated 3-4 weeks post-op) ]

Central Contacts and Locations

Central contacts

Ethan D Jones, MPH

8026569437ethan.d.jones@med.uvm.edu

OCTR Main Line

8026561313

Locations

UVM Medical Center

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Ethan D Jones, MPH

802-656-9437ethan.d.jones@med.uvm.edu

OCTR Main Line

8026561313

More Information

Sponsor

University of Vermont

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2022-10-14.