Ropivacaine Concentration and Rebound Pain

NCT ID: NCT06950372

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2026-12-31

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 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.

Conditions

Radius Fracture Distal; Rebound Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low concentration

Ropivacaine 3.75 mg/ml

Group Type: EXPERIMENTAL

Ropivacaine concentration low

Intervention Type: DRUG

Brachial plexus nerve block with ropivacaine 3.75 mg/ml

High concentration

Ropivacaine 7.5 mg/ml

Group Type: ACTIVE_COMPARATOR

Ropivacaine concentration high

Intervention Type: DRUG

Brachial plexus nerve block with ropivacaine 7.5 mg/ml

Interventions

Ropivacaine concentration low

Brachial plexus nerve block with ropivacaine 3.75 mg/ml

Intervention Type: DRUG

Ropivacaine concentration high

Brachial plexus nerve block with ropivacaine 7.5 mg/ml

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anette Aasen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anette Aasen, MD, Anesthesiologist

Role: PRINCIPAL_INVESTIGATOR

University of Oslo and Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anette Aasen, MD, Anesthesiologist

Role: CONTACT

anette.aasen@medisin.uio.no

+47 22119690

Anne Holmberg, MD, PhD, Anesthesiologist

Role: CONTACT

hnea@ous-hf.no

+47 22119690

Facility Contacts

Anette Aasen, MD

Role: primary

anette.aasen@medisin.uio.no

+47 22119690

Anne Holmberg, MD, PhD, Anaesthesiologist

Role: backup

Other Identifiers

2024-514795-41-00

Identifier Type: CTIS

Identifier Source: secondary_id

EU CT 2024-514795-41-00

Identifier Type: -

Identifier Source: org_study_id