Ropivacaine Concentration and Rebound Pain

NCT06950372 | Completed Phase 4

• 2 other identifiers: EU CT 2024-514795-41-002024-514795-41-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Rebound pain; Peripheral nerve block; Distal radius fracture; Brachial plexus block; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Worst pain score during the first 48 hours after surgery

  Pain score on Verbal Numeric Rating Scale (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.

  48 hours after end of surgery

Secondary Outcomes (11)

• Rebound pain

  From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.

• Pain score at different points of time after surgery

  From baseline, end of surgery, until 6 weeks after surgery.

• Duration of moderate and strong pain

  From baseline, end of surgery, until first time patient reports VNRS below 7 and/or 4, normally within the first 48 hours.

• Average and worst pain experience after surgery at different points of time

  From baseline, end of surgery, until 7 days after surgery.

• Long-lasting pain

  From baseline, end of surgery, until 6 weeks after surgery.

Study Arms (2)

Low concentration

EXPERIMENTAL

Ropivacaine 3.75 mg/ml

Drug: Ropivacaine concentration low

High concentration

ACTIVE COMPARATOR

Ropivacaine 7.5 mg/ml

Drug: Ropivacaine concentration high

Interventions

Ropivacaine concentration low DRUG

Brachial plexus nerve block with ropivacaine 3.75 mg/ml

Low concentration

Ropivacaine concentration high DRUG

Brachial plexus nerve block with ropivacaine 7.5 mg/ml

High concentration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with distal radius fracture, scheduled for volar plate surgery
• Surgery up to 20 days after fracture trauma
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Anette Aasen, MD, Anesthesiologist

  University of Oslo and Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 30, 2025
• Study Start: February 14, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)