A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Vermont
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Failure Rate
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Note: Eligibility will be determined by the research coordinator and approved by the surgeon
Arms & Interventions
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.
Intervention: Non-Narcotic ERAS Post-Operative Pain Management (Other)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Patient Satisfaction(Until post-op clinic visit (estimated 3-4 weeks post-op))
Investigators
Peter Cataldo, MD
Colon and Rectal Surgeon, General Surgeon, Professor of Surgery
University of Vermont