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Non-Narcotic Pain Management for Postoperative Pain Following Colectomy
Phase 4
Recruiting
Led By Peter Cataldo, MD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing elective abdominal colectomy
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until post-op clinic visit (estimated 3-4 weeks post-op)
Awards & highlights
Study Summary
This trial is testing whether patients can manage post-operative pain after colon surgery without narcotic drugs, which can be addictive and have harmful side effects.
Who is the study for?
This trial is for adults over 18 who are scheduled for elective abdominal colectomy and can follow the ERAS protocol. It's not for those with plans for a stoma, rectal cancer diagnosis, recent narcotic use, dementia, chronic pain, allergies to study drugs, urgent surgeries or other malignancies.Check my eligibility
What is being tested?
The study tests if non-narcotic pain management after colectomy can control pain effectively without narcotics. This pilot aims to reduce reliance on opiates by proving that alternative analgesics work well enough to support a larger future trial.See study design
What are the potential side effects?
While specific side effects aren't listed here, non-narcotic analgesics may include risks like stomach upset, headaches, dizziness or allergic reactions but generally have fewer complications than narcotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for elective surgery to remove part of my colon.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until post-op clinic visit (estimated 3-4 weeks post-op)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until post-op clinic visit (estimated 3-4 weeks post-op)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Failure Rate
Secondary outcome measures
Patient Satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
267 Previous Clinical Trials
3,743,716 Total Patients Enrolled
1 Trials studying Postoperative Pain
80 Patients Enrolled for Postoperative Pain
Peter Cataldo, MDPrincipal InvestigatorUniversity of Vermont Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for the special recovery program after colon surgery at UVMMC.My pain level is more than 2 out of 10.You have dementia.I experience chronic pain.I am scheduled for surgery that will result in a stoma.I am scheduled for elective surgery to remove part of my colon.I am receiving or have received chemotherapy and radiation before surgery.I have been diagnosed with rectal cancer before any surgery.You have used strong painkillers for more than one week within three months of your scheduled surgery date.I am 18 years old or older.You are allergic to any of the study medications.I have cancer that has spread beyond my colon.I have had emergency surgery on my intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining for individuals to join this experiment?
"According to the clinicaltrials.gov website, this trial is searching for participants as of 10/13/2022 and was first made available on 2/7/2022."
Answered by AI
Has this intervention been given the green light from federal regulatory bodies?
"The safety of this treatment is deemed safe enough to receive a score of 3, since it has already been approved and certified by the FDA after an extensive Phase 4 trial."
Answered by AI
How many participants has this clinical trial enrolled thus far?
"Affirmative, clinicaltrials.gov informs that this medical trial is searching for participants and was initially posted on February 7th 2022 with the last update taking place October 13th of the same year. 25 patients are needed to enrol at 1 designated site."
Answered by AI
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