Evaluating pain relief methods for ACL repair surgery
Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair
This study is testing if adding dexamethasone and dexmedetomidine to pain relief methods can help people recovering from ACL repair surgery feel less pain for a longer time.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03643822 on ClinicalTrials.gov |
What this trial studies
This multi-centered study aims to assess the effectiveness of two adjuncts, dexamethasone and dexmedetomidine, and their combination, in enhancing postoperative pain relief for patients undergoing Anterior Cruciate Ligament (ACL) repair. The study focuses on improving the duration of analgesia provided by the adductor canal block (ACB), which typically lasts only eight hours post-surgery. By incorporating these adjuncts, the researchers hope to reduce the need for additional opioid analgesics and emergency department visits due to pain. The study will involve English-speaking patients with specific health criteria to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients classified as ASA 1-3 with a BMI under 40 undergoing ACL repair.
Not a fit: Patients with contraindications to regional anesthesia, significant psychiatric conditions, or a history of chronic pain disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve postoperative pain management for ACL repair patients, leading to better recovery experiences.
How similar studies have performed: Previous studies have shown that similar adjuncts can effectively prolong analgesia duration, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English Speaking * ASA 1-3 patients * BMI \<40 Exclusion Criteria: * Refusal or inability to provide informed consent * Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block * History of alcohol/drug dependence * History of long term opioid intake or chronic pain disorder * History of preexisting neuropathy in the operative leg * History of significant psychiatric conditions that may affect patient assessment * Inability to understand the informed consent and demands of the study * Allergy to any of the components of the multimodal analgesic regimen * Revision of ACL repair * Diabetes * Significant bradycardia (baseline heart rate ≤ 40 beats per minute)
Where this trial is running
Toronto, Ontario
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Richard Brull, MD — Women's College Hospital
- Study coordinator: Didem Bozak
- Email: didem.bozak@wchospital.ca
- Phone: 416-323-6008
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.