Nonopioid pain management after shoulder surgery
Traditional vs. Nonopioid Analgesia After Labral Surgery
PHASE2; PHASE3 · Henry Ford Health System · NCT03825809
This study tests whether a nonopioid pain management approach can help adults recovering from shoulder surgery feel less pain compared to the usual opioid treatment.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System (other) |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT03825809 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares postoperative pain control in patients undergoing rotator cuff repair by evaluating two treatment approaches: a nonopioid pain control regimen and a standard opioid pain control regimen. Adult patients over 18 years old who are scheduled for primary or revision labral surgery will be randomly assigned to one of the two groups. Pain levels will be assessed using a visual analog scale (VAS) and PROMIS metrics at various postoperative intervals. The study aims to determine the effectiveness of nonopioid analgesia in managing pain after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for primary or revision labral surgery.
Not a fit: Patients with a history of narcotic use within the last 6 months or those with specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective nonopioid alternative for pain management, reducing reliance on narcotics post-surgery.
How similar studies have performed: Previous studies have shown promise in using nonopioid analgesics for pain management in similar surgical contexts, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria: Inclusion Criteria: * All adult patients over age 18 and scheduled for a primary or revision labral surgery Exclusion Criteria: * Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Where this trial is running
Detroit, Michigan
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Toufic R Jildeh, MD — Henry Ford Health System
- Study coordinator: Toufic R Jildeh, MD
- Email: tjildeh1@hfhs.org
- Phone: 517-230-8511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Narcotic Use