Status:
RECRUITING
Ropivacaine Concentration and Rebound Pain
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Oslo
Conditions:
Radius Fracture Distal
Rebound Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fracture...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06950372
Start Date
February 14 2025
End Date
December 1 2026
Last Update
April 30 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway