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

October 13, 2022 updated by: Peter Cataldo, MD, University of Vermont
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.
  • Search for patterns pain and in timing of need for narcotic medication (e.g. in PACU, after intrathecal morphine wear off, etc.)

Secondary objectives:

  • Measure patient satisfaction with pain management via survey administered at discharge and during the 30 days post-operation. This will include questions regarding medication side-effects.
  • Determine factors that may affect patient need for narcotic pain medication, including complications (return to OR, anastomotic leak, prolonged ileus, post-operative hemorrhage), return of bowel function, side effects of medications, and length of hospital stay, which will be taken from patients' charts and surveys for analysis.

Procedures:

At their initial clinic visit for surgical scheduling, patients will be explained appropriate risks and benefits of participating in this pilot program. If interested, patients will choose to opt in to the protocol and consent to participate at this time. Pre-operatively, patients will adhere to the Enhanced Recovery After Surgery (ERAS) protocol in standard use at UVMMC for colectomy patients. This protocol includes administration of gabapentin (900 mg capsule), acetaminophen (1,000 mg tablet), dexamethasone (8 mg intravenously), granisetron (1 mg intravenously), and morphine (0.15 mg intrathecally). Appropriate medications will be administered at the discretion of the treating anesthesiologist during colectomy, but ketamine use will be encouraged if not contraindicated. Following the completion of colectomy, patients will only be given oral acetaminophen (650 mg, every 4 hours), gabapentin (300 mg, every 6 hours), methocarbamol (750mg, 4 times daily), and 5% lidocaine pat (every 12 hours, as needed), for analgesia from their stay in the PACU onwards. A one-time opioid rescue prescription for hydromorphone, morphine, or oxycodone will be available for breakthrough pain during their hospital stay. This differs from standard ERAS post-operative pain management, where hydromorphone, morphine, or oxycodone can be administered as needed. If a patient uses the one-time rescue dose, the covering physician will be notified and can then choose to order an appropriate narcotic regimen for the remainder of the patient's hospitalization. All patients will be discharged with a narcotics prescription that they can choose to fill. Throughout their hospitalization, patients will be asked to provide their pain level on the Visual Analog Scale (VAS) per typical protocol. At discharge, they will be given instructions for weaning pain medications at home. They will also be provided a medication diary, where they will record their pain levels, the time of administration of pain medications, and the name of the medications being administered. A patient satisfaction survey will be provided with the medication diary. The patient will be instructed to fill out the survey when they return home after discharge and to return the survey with their medication diary at their first follow up visit. An automated telephone call will occur daily for 1 week after discharge to remind the patient to record their pain level and medication use in the medication diary. At the patient's follow-up clinic visit, which occurs 3-4 weeks after discharge, the patient will bring their completed medication diary and first satisfaction survey. At this visit, a second patient satisfaction survey will be completed.

Outcome measures will be monitored through use of the rescue prescription while hospitalized, as well as self-reported surveys measuring post-operative pain, protocol side effects, and satisfaction of pain control, which will be given to the patients at discharge and at a follow-up clinic visit. Information on return of bowel function, length of hospital stay, and other medical complications will be gleaned from the patients' charts. Analysis of outcomes will be performed with the aid of a statistician.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: OCTR Main Line
  • Phone Number: 8026561313

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • UVM Medical Center
        • Contact:
          • OCTR Main Line
          • Phone Number: 8026561313
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Non-Narcotic ERAS Post-Operative Pain Management
As described previously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure Rate
Time Frame: Until post-op clinic visit (estimated 3-4 weeks post-op)
Need for rescue narcotics for inadequately controlled pain as indicated in Electronic Medical Record (EMR).
Until post-op clinic visit (estimated 3-4 weeks post-op)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Until post-op clinic visit (estimated 3-4 weeks post-op)
Patient satisfaction with pain management via satisfaction survey administration at discharge and during the 30 days post-operation.
Until post-op clinic visit (estimated 3-4 weeks post-op)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Peter Cataldo, MD, University of Vermont Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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