Ropivacaine Concentration and Rebound Pain

Phase 4

Recruiting

• Conditions: Radius Fracture Distal; Rebound Pain
• Interventions: Drug: Ropivacaine concentration low; Drug: Ropivacaine concentration high

• Registration Number: NCT06950372
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-14
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low concentration	Ropivacaine concentration low	Ropivacaine 3.75 mg/ml
High concentration	Ropivacaine concentration high	Ropivacaine 7.5 mg/ml

Primary Outcome Measures

Name	Time	Method
Worst pain score during the first 48 hours after surgery	48 hours after end of 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.

Secondary Outcome Measures

Name	Time	Method
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.	Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.; Duration of moderate pain, defined as time from VNRS above or equal to 4, after block resolution to first time patient reports VNRS below 4.; Duration of strong pain, defined as time from VNRS above or equal to 7, after block resolution to first time patient reports VNRS below 7.
Average and worst pain experience after surgery at different points of time	From baseline, end of surgery, until 7 days after surgery.	Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.; Average pain score (VNRS 0-10) at 8-24 hours after surgery, 24-48 hours after surgery, last 24 hours at 3 days and 7 days after surgery.; Worst pain score (VNRS 0-10) at 8-24 hours after surgery, 24-48 hours after surgery, last 24 hours at 3 days and 7 days after surgery.
Long-lasting pain	From baseline, end of surgery, until 6 weeks after surgery.	Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.; Pain score (VNRS 0-10) at rest and with movement of arm at 6 weeks after surgery.; Worst pain (VNRS 0-10) during last week at 6 weeks after surgery.; Average pain (VNRS 0-10) during last week at 6 weeks after surgery.
Analgesic consumption after surgery	From baseline, end of surgery, until 6 weeks after surgery.	Total opioid consumption, measured in oral morphine equivalent, first 8 hours, first 24 hours, 24-48 hours, 48-72 hours, 72 hours to 1 week and last week at 6 weeks after surgery.; Total analgesic consumption at the same times as above.
Duration of motoric and sensoric nerve block	From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention.	Duration of motoric block: Time from nerve block (needle out) to first time the patient can hold an item with the blocked arm and lift i to the mouth area.; Duration of sensory block: Time from nerve block (needle out) to first sensation of pain.; We will also register time from nerve block (needle out) to first rescue analgesic.
Life quality	From baseline, end of surgery, until 6 weeks after surgery	Estimation of pain burden with different quality of life measures at different time points after surgery: Quality of sleep, work ability, social life and cognitive function using Likert Scale.; Number of patients answering "yes" to the question: "Do you have bothersome pain?".; Measures registered 24 hours, 48 hours, 72 hours, 1 week and 6 weeks after surgery.
Quality of long-term pain	6 weeks after baseline, intervention and surgery.	If long-term pain, what type of pain is experienced (heat, cold, burning, prickly, tingling, itchy, squeezing). Registration of pain quality without direct stimulation and after direct stimulation in surgery area and 5-10 cm away from surgery area.
Patient satisfaction	From enrollment until 6 weeks after surgery	Yes or no to the question; "Are you satisfied with the pain treatment?"
Block success rate	From intervention, when nerve block is performed, until 2 hours after surgery.	Try to estimate if there is a difference in block success rate between the two concentrations. Sensory and/or motor test of relevant nerves (musculocutaneous, radial, median, ulnar and medial antebrachial cutaneus nerve) before surgery (45 minutes after nerve block and repeated if necessary) and in Post Anesthesia Care Unit (PACU) after surgery.; In addition, yes or no to the question; "Was the block adequate for surgery?" (Registered by anaesthetic personell during surgery)
Rebound pain	From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.	Number of patients reporting pain score on Verbal Numeric Rating Score (VNRS) of 7 or higher at nerve block resolution, where 0 represents no pain at all and 10 represents worst pain imaginable.
Pain score at different points of time after surgery	From baseline, end of surgery, until 6 weeks after surgery.	Pain score 0 to 10 on Verbal Numeric Rating Score (VNRS), where 0 represents no pain at all and 10 represents worst pain imaginable. Pain Score (VNRS 0-10) measured in the Post Anaesthesia Care Unit (PACU) and at 4 hours, 8 hours, 24 hours, 48 hours, 3 days, 7 days and 6 weeks after surgery.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway