Comparing two anesthetics for pain relief during treatment of wrist fractures
Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial
PHASE3 · Nordsjaellands Hospital · NCT06379490
This study is testing whether two different local anesthetics, lidocaine and ropivacaine, can provide better pain relief for people getting treatment for wrist fractures.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nordsjaellands Hospital (other) |
| Locations | 1 site (Hillerød) |
| Trial ID | NCT06379490 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the lateral infraclavicular plexus brachialis block for providing pain relief during the closed reduction of distal radius fractures. It compares the pain-relieving and muscle-relaxing effects of two local anesthetics, lidocaine and ropivacaine, at different concentrations but the same volume. The study will assess not only the effectiveness of the anesthetics but also various patient-related and procedural factors that may influence the feasibility of the block. The goal is to determine the best approach for managing pain during this common orthopedic procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a distal radius fracture that requires closed reduction.
Not a fit: Patients with a BMI over 40 kg/m2, those under 18 years old, or those with certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for patients undergoing treatment for wrist fractures.
How similar studies have performed: Previous studies have shown promising results with similar approaches to regional anesthesia for orthopedic procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who have given written informed consent to participate in the study after having understood it, as well as: • Having a distal radius fracture requiring closed reduction Exclusion Criteria: Patients who meet one or more of the following criteria will be excluded from participating in the study: * BMI \> 40 kg/m2 * Weight \< 50 kg * Age \< 18 years * American Society of Anesthesiologists (ASA) physical status classification system grade \>3 * Allergy to experimental drugs * Patients who cannot cooperate with the examinations or treatment * Patients who do not understand or speak Danish * Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required
Where this trial is running
Hillerød
- Copenhagen University Hospital - North Zealand — Hillerød, Denmark (RECRUITING)
Study contacts
- Principal investigator: Anders K. Nørskov, PhD — Copenhagen University Hospital - North Zealand
- Study coordinator: Anders K. Nørskov, PhD
- Email: anders.kehlet.noerskov@regionh.dk
- Phone: 48 29 74 59
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: Distal Radius Fractures, Lidocaine, Ropivacaine, Fracture Dislocation, Closed Reduction of Fracture and Application of Plaster Cast, Colles' Fracture, anesthetics, local, regional anesthesia