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

NCT05200806 | Unknown Phase 4 FDA Drug

• 1 other identifier: STUDY00000915
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Failure Rate

  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 Outcomes (1)

• Patient Satisfaction

  Until post-op clinic visit (estimated 3-4 weeks post-op)

Study Arms (1)

Intervention

OTHER

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

Interventions

Non-Narcotic ERAS Post-Operative Pain Management OTHER

As described previously.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• dementia
• Note: Eligibility will be determined by the research coordinator and approved by the surgeon

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

UVM Medical Center

Burlington, Vermont, 05405, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 27631771 BACKGROUND

• 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.

  PMID: 27400458 BACKGROUND

• 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.

  PMID: 31270113 BACKGROUND

• 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.

  PMID: 31318765 BACKGROUND

• 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.

  PMID: 25480622 BACKGROUND

• 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.

  PMID: 30244594 BACKGROUND

• 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.

  PMID: 31154092 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Breakthrough Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Peter Cataldo, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethan D Jones, MPH

CONTACT

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

OCTR Main Line

CONTACT

8026561313

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colon and Rectal Surgeon, General Surgeon, Professor of Surgery

Model Details: Prospective Cohort Study, without randomization, and evaluation of a single intervention.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: January 21, 2022
• Study Start: February 7, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)