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Opioid-Free Pain Control for Orthopaedic Surgery Recovery (CORE Trial)
N/A
Waitlist Available
Led By Nady M Hamid, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CORE Trial Summary
This trial will compare the safety and effectiveness of two different pain control strategies following routine orthopedic surgery. One group of patients will receive opioids for pain control, while the other group will receive a multimodal, opioid-free pain control strategy. Data will be collected on pain scores, overall comfort level, satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control.
Who is the study for?
This trial is for adults needing certain orthopaedic surgeries, like spine or joint replacements, without a history of substance dependence, significant liver disease, renal insufficiency, GI bleeding/ulcers, or chronic opioid use. It excludes those on workers' comp., with alcohol dependence, taking strong anticoagulants (except aspirin), having outpatient procedures or revision surgeries.Check my eligibility
What is being tested?
The study compares two pain management methods after routine orthopaedic surgery: one uses opioids and the other an opioid-free approach. Patient comfort, satisfaction with surgery and recovery, pain control effectiveness and side effects like constipation and falls will be measured.See study design
What are the potential side effects?
Opioid-based protocols may lead to nausea, constipation, drowsiness or risk of addiction. The opioid-free method might include discomfort due to less familiar pain control techniques but aims to avoid these specific opioid-related side effects.
CORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
General Health
Pain at 1 year postop
Pain at 12 hours postop
+3 moreCORE Trial Design
2Treatment groups
Active Control
Group I: OpioidActive Control1 Intervention
The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone.
Group II: Opioid-FreeActive Control1 Intervention
The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac.
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Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
34 Previous Clinical Trials
5,420 Total Patients Enrolled
Nady M Hamid, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a problem with drinking too much alcohol and are dependent on it.You have a history of bleeding or ulcers in your stomach or intestines.You have a history of bleeding issues.You are allergic to medications called NSAIDs.You had surgery on one or two levels of your neck for degenerative disease.You have had a knee procedure called arthroscopy to diagnose and possibly remove damaged tissue in the knee joint.You cannot receive regional anesthesia due to medical reasons.You have hammertoe, but it's not a problem as long as you don't have Hallux Valgus or Rigidus.You recently had surgery to repair your meniscus or undergo microfracture in your knee.You are currently taking opioid pain medication on a long-term basis, as decided by the doctor.You have had a previous surgery called Primary 1st CMC arthroplasty.You have a foot condition called Hallux Valgus or Hallux Rigidus that needs to be corrected.You have planned to have a surgery to replace your shoulder joint.You have recently broken a bone or injured your soft tissues.You have recently had a hip replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid
- Group 2: Opioid-Free
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.
Are enrollees still being accepted into this research endeavor?
"Unfortunately, the details of this medical trial reported on clinicaltrials.gov indicate that it is not currently seeking participants; however, since its posting date of March 26th 2018 and recent edit on April 20th 2022, 34 additional trials have opened up for enrolment."
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