A Phase 4 interventional study of Non-Narcotic ERAS Post-Operative Pain Management in Analgesia, Post-Operative Pain and Breakthrough Pain, sponsored by University of Vermont. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by University of Vermont · Phase 4, Interventional, and Treatment
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.
Our primary objectives are:
Secondary objectives:
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 25 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Eligibility will be determined by the research coordinator and approved by the surgeon
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Failure Rate
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)
Patient Satisfaction
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)
Plan to share: No
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