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Pain Management Strategies for Postoperative Pain (eNARCOS Trial)
N/A
Recruiting
Led By Andrew Zakhari, M.D.
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned for same day discharge
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 7
Awards & highlights
eNARCOS Trial Summary
This trial is testing different discharge prescriptions to find the best way to control pain after laparoscopic gynecologic surgery.
Who is the study for?
This trial is for women who can consent, are having elective outpatient gynecologic laparoscopy, and plan to go home the same day. It's not for those with chronic pain conditions, severe mental health issues, substance abuse history, poor physical performance status or recent use of certain pain medications.Check my eligibility
What is being tested?
The study is testing two different post-surgery pain control prescriptions: one with acetaminophen and naproxen; another adds dilaudid (an opioid). Patients will be randomly assigned to a regimen to see which manages pain effectively while maintaining patient satisfaction in the first week after surgery.See study design
What are the potential side effects?
Possible side effects from acetaminophen and naproxen include stomach upset and liver issues. Dilaudid can cause nausea/vomiting, dizziness, constipation, risk of addiction or worsening pre-existing substance abuse problems.
eNARCOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled to leave the hospital on the same day as my procedure.
eNARCOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day one and seven
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day one and seven
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Opioid related side effect
Overall satisfaction with pain control
Pain score on post-operative day one
+3 moreeNARCOS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Acetaminophen and naproxen only armExperimental Treatment1 Intervention
Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration.
Group II: Acetaminophen, naproxen and dilaudid armActive Control1 Intervention
Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line.
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
447 Previous Clinical Trials
159,664 Total Patients Enrolled
Andrew Zakhari, M.D.Principal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
2 Previous Clinical Trials
61 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery complications needing a larger incision, organ injury, significant bleeding, or hospital stay.I have been diagnosed with depression or anxiety, with or without medication.I have been using medications like pregabalin or gabapentin for pain.I am scheduled to leave the hospital on the same day as my procedure.I need considerable assistance and am unable to carry out any work activities.I am allergic to acetaminophen, NSAIDs, or narcotics like hydromorphone.I have a chronic pain condition such as fibromyalgia or severe arthritis.You have a history of using drugs in a way that can be harmful, such as becoming addicted to opioids or injecting drugs into your veins.I am a woman scheduled for outpatient gynecologic surgery.I regularly use pain medication.
Research Study Groups:
This trial has the following groups:- Group 1: Acetaminophen, naproxen and dilaudid arm
- Group 2: Acetaminophen and naproxen only arm
Awards:
This trial has 1 awards, including:- 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.
To what extent is this clinical trial being populated with participants?
"Affirmative, the clinical trial is still recruiting individuals. The details of this study were originally posted on July 4th 2022 and last amended on September 6th 2022. 80 volunteers are needed from one single medical facility."
Answered by AI
Are any new participants currently being accepted for the clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical research was initially posted on July 4th 2022 and is presently searching for 80 participants from a single site. Recent updates were made on September 6th of the same year."
Answered by AI
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