Ropivacaine Concentration and Rebound Pain

University of Oslo (UIO)

Status and phase: Enrolling; Phase 4

Conditions: Radius Fracture Distal; Rebound Pain

Treatments: Drug: Ropivacaine concentration high; Drug: Ropivacaine concentration low

Study type: Interventional

Funder types: Other

Identifiers

NCT06950372

EU CT 2024-514795-41-00

2024-514795-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

Low concentration

Experimental group

Description:

Ropivacaine 3.75 mg/ml

Treatment:

Drug: Ropivacaine concentration low

High concentration

Active Comparator group

Description:

Ropivacaine 7.5 mg/ml

Treatment:

Drug: Ropivacaine concentration high