Clinical trial NCT06950372: Ropivacaine Concentration and Rebound Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Radius Fracture Distal
Rebound Pain
Keywords: Rebound pain
Peripheral nerve block
Distal radius fracture
Brachial plexus block
Ropivacaine
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2025-04-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Worst pain score during the first 48 hours after surgery
timeFrame: 48 hours after end of surgery
Secondary outcomes:
measure: Rebound pain
timeFrame: From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.
measure: Pain score at different points of time after surgery
timeFrame: From baseline, end of surgery, until 6 weeks after surgery.
measure: Duration of moderate and strong pain
timeFrame: From baseline, end of surgery, until first time patient reports VNRS below 7 and/or 4, normally within the first 48 hours.
measure: Average and worst pain experience after surgery at different points of time
timeFrame: From baseline, end of surgery, until 7 days after surgery.
measure: Long-lasting pain
timeFrame: From baseline, end of surgery, until 6 weeks after surgery.
measure: Analgesic consumption after surgery
timeFrame: From baseline, end of surgery, until 6 weeks after surgery.
measure: Duration of motoric and sensoric nerve block
timeFrame: From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention.
measure: Life quality
timeFrame: From baseline, end of surgery, until 6 weeks after surgery
measure: Quality of long-term pain
timeFrame: 6 weeks after baseline, intervention and surgery.
measure: Patient satisfaction
timeFrame: From enrollment until 6 weeks after surgery
measure: Block success rate
timeFrame: From intervention, when nerve block is performed, until 2 hours after surgery.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo and Oslo University Hospital
name: Anette Aasen, MD, Anesthesiologist
role: PRINCIPAL_INVESTIGATOR
References: