search
Back to results

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

Primary Purpose

Analgesia, Post-Operative Pain, Breakthrough Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Non-Narcotic ERAS Post-Operative Pain Management
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UVM Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Failure Rate
Need for rescue narcotics for inadequately controlled pain as indicated in Electronic Medical Record (EMR).

Secondary Outcome Measures

Patient Satisfaction
Patient satisfaction with pain management via satisfaction survey administration at discharge and during the 30 days post-operation.

Full Information

First Posted
November 10, 2021
Last Updated
October 13, 2022
Sponsor
University of Vermont
search

1. Study Identification

Unique Protocol Identification Number
NCT05200806
Brief Title
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
Official Title
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Post-Operative Pain, Breakthrough Pain, Colectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort Study, without randomization, and evaluation of a single intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non-Narcotic ERAS Post-Operative Pain Management
Intervention Description
As described previously.
Primary Outcome Measure Information:
Title
Failure Rate
Description
Need for rescue narcotics for inadequately controlled pain as indicated in Electronic Medical Record (EMR).
Time Frame
Until post-op clinic visit (estimated 3-4 weeks post-op)
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction with pain management via satisfaction survey administration at discharge and during the 30 days post-operation.
Time Frame
Until post-op clinic visit (estimated 3-4 weeks post-op)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan D Jones, MPH
Phone
8026569437
Email
ethan.d.jones@med.uvm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
OCTR Main Line
Phone
8026561313
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cataldo, MD
Organizational Affiliation
University of Vermont Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVM Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan D Jones, MPH
Phone
802-656-9437
Email
ethan.d.jones@med.uvm.edu
First Name & Middle Initial & Last Name & Degree
OCTR Main Line
Phone
8026561313

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27631771
Citation
Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
Results Reference
background
PubMed Identifier
27400458
Citation
Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum In: JAMA Intern Med. 2016 Sep 1;176(9):1412. JAMA Intern Med. 2022 Jun 1;182(6):690. JAMA Intern Med. 2022 Jul 1;182(7):783.
Results Reference
background
PubMed Identifier
31270113
Citation
Zin CS, Nazar NI, Rahman NSA, Ahmad WR, Rani NS, Ng KS. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naive patients in Malaysia: a retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e027203. doi: 10.1136/bmjopen-2018-027203.
Results Reference
background
PubMed Identifier
31318765
Citation
Fields AC, Cavallaro PM, Correll DJ, Rubin MS, Sequist T, Khawaja A, Yao Y, Bordeianou LG, Bleday R. Predictors of Prolonged Opioid Use Following Colectomy. Dis Colon Rectum. 2019 Sep;62(9):1117-1123. doi: 10.1097/DCR.0000000000001429.
Results Reference
background
PubMed Identifier
25480622
Citation
Alvarez MP, Foley KE, Zebley DM, Fassler SA. Comprehensive enhanced recovery pathway significantly reduces postoperative length of stay and opioid usage in elective laparoscopic colectomy. Surg Endosc. 2015 Sep;29(9):2506-11. doi: 10.1007/s00464-014-4006-8. Epub 2014 Dec 6.
Results Reference
background
PubMed Identifier
30244594
Citation
Sobel DW, Cisu T, Barclay T, Pham A, Callas P, Sternberg K. A Retrospective Review Demonstrating the Feasibility of Discharging Patients Without Opioids After Ureteroscopy and Ureteral Stent Placement. J Endourol. 2018 Nov;32(11):1044-1049. doi: 10.1089/end.2018.0539. Epub 2018 Oct 23.
Results Reference
background
PubMed Identifier
31154092
Citation
Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs