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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 fractures in adults. The main questions it aims to answer are: * Is concentration of ropivacaine related to severeness, duration and type of postoperative pain? * Is concentration of ropivacaine related to analgetic consumption after surgery? * Is concentration of ropivacaine related to block sucess rate during surgery and patient satisfaction after surgery? Researchers will compare ropivacaine 3.75 mg/ml and 7.5 mg/ml used in brachial plexus peripheral nerve block. Participipants are randomized to one of the two concentrations. The peripheral nerve block is standard anesthetic treatment for distal radius fractures scheduled for volar plate surgery at Oslo University Hospital. All other treatment for the condition will be the same as standard treatment. Participants will answer a questionnaire regarding pain, physical function, medication and life quality at different points of time after surgery, up to 6 weeks after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Anette Aasen, MD, Anesthesiologist
anette.aasen@medisin.uio.no
+47 22119690
Backup
Anne Holmberg, MD, PhD, Anesthesiologist
hnea@ous-hf.no
+47 22119690
Time Frame
Start Date: 2025-02-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Low concentration
Ropivacaine 3.75 mg/ml
Active_comparator: High concentration
Ropivacaine 7.5 mg/ml
Related Therapeutic Areas
Sponsors
Collaborators: University of Oslo
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov