Examining the effect of ropivacaine concentration on pain after wrist surgery
Rebound Pain After Volar Plate Surgery in Infraclavicular Brachial Plexus Block With Ropivacaine 3.75 mg/ml Compared With 7.5 mg/ml. A Prospective, Parallelgroup, 2-arm, Triple Blinded Randomised Controlled Trial
This study tests whether using different strengths of ropivacaine can help adults having wrist surgery feel less pain afterwards.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06950372 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the relationship between the concentration of ropivacaine, a local anesthetic, and the severity of postoperative pain in adults undergoing surgery for distal radius fractures. Participants will be randomly assigned to receive either a low or high concentration of ropivacaine during a brachial plexus peripheral nerve block. The study aims to assess how these concentrations affect pain severity, duration, analgesic consumption, and patient satisfaction post-surgery. All other aspects of treatment will follow standard protocols at Oslo University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a distal radius fracture scheduled for surgery within 20 days of injury.
Not a fit: Patients with existing long-term pain or those using opioids or psychotropic drugs prior to the fracture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing wrist surgery.
How similar studies have performed: Previous studies have shown varying success with local anesthetic concentrations, but this specific approach is novel in the context of distal radius fractures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with distal radius fracture, scheduled for volar plate surgery * Surgery up to 20 days after fracture trauma * 18 to 80 years old (inclusive) * ASA 1, 2 or stable ASA 3 * Body Mass Index (BMI) 18 to 40 kg/m2 (inclusive) * Weight of 50 kg or more * Ability to communicate sufficiently in a scandinavian language * Capable of giving a signed informed consent * Ability and willingness to understand og be compliant to the study Exclusion Criteria: * Contemporaneous painful injuries * Existing long-term pain * Peripheral nerve damage in the arm with radius fracture * Patients who prior to fracture trauma use opioids, psycothropic drugs or medication, with or without prescription, with significantly sedative effect on regular basis. * Excessive use of alcohol (more than 15 units of alchol per week for men, more than 8 units of alchol per week for women, or patients reporting to be incapable of avoiding alcohol as long as they use strong opioids). * Progressive neurologic disease (inclusive diabetic neuropathy). * Skin infection at the site for brachial plexus nerve block * Other contraindications for brachial plexus nerve block * Contraindications for ropivacaine, paracetamol, etoricoxib, dexamehtasone or oxycodone * Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol. * Pregnant or breast-feeding women at surgery day (they do not get excluded if they become pregnant in the follow up period after intervention and surgery)
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Anette Aasen, MD, Anesthesiologist — University of Oslo and Oslo University Hospital
- Study coordinator: Anette Aasen, MD, Anesthesiologist
- Email: anette.aasen@medisin.uio.no
- Phone: +47 22119690
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.