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, triple blinded randomised controlled trial
- Conditions
- Radius fracture
- Registration Number
- 2024-514795-41-00
- Lead Sponsor
- Oslo University Hospital HF
- Brief Summary
To investigate if severity of postoperative pain may be related to the concentration of ropivacaine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Adult patients with radius fracture, scheduled for volar plate surgery within 20 days after the fracture trauma
ASA I, II and stable ASA III patients
Body Mass Index (BMI) 18-40 kg/m2
Body weight 50 kg or above
Ability to understand and communicate sufficiently in a Scandinavian language
Capable of giving signed informed consent
Progressive neurologic disease
Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.
Existing long-term pain
Peripheral nerve damage in the fractured arm
Breast-feeding women or women pregnant on the inclusion day
Contraindications for ropivacaine, etoricoxib, dexamethasone, paracetamol or oxycodone
Excessive intake of alcohol or illegal drugs
Use of opioids, psychotropic drugs, sleep medication or medication with sedative effect on a regular basis prior to fracture trauma.
Other painful injuries
Skin infection or other contraindications for brachial plexus nerve block
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10 Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10
- Secondary Outcome Measures
Name Time Method Rebound pain, defined as VNRS (0-10) equal or above 7 at block resolution Rebound pain, defined as VNRS (0-10) equal or above 7 at block resolution
Difference in VNRS and Likert scale in the post anesthesia care unit (PACU) 8 hours, 24 hours, 48 hours, 3 days and 7 days after surgery. Difference in VNRS and Likert scale in the post anesthesia care unit (PACU) 8 hours, 24 hours, 48 hours, 3 days and 7 days after surgery.
Duration of moderate pain (VNRS 4 or above) and strong pain (VNRS 7 or above). Duration of moderate pain (VNRS 4 or above) and strong pain (VNRS 7 or above).
Average and worst pain score (VNRS) 8-24 hours, 24-48 hours, last 24 hours at 3 days and 7 days after surgery. Average and worst pain score (VNRS) 8-24 hours, 24-48 hours, last 24 hours at 3 days and 7 days after surgery.
Pain at rest and with movement at 6 weeks after surgery (VNRS 0-10 and Likert scale) Pain at rest and with movement at 6 weeks after surgery (VNRS 0-10 and Likert scale)
Worst pain last week at 6 weeks after surgery and average pain last 24 hours at 6 weeks after surgery. Worst pain last week at 6 weeks after surgery and average pain last 24 hours at 6 weeks after surgery.
Total opioid and analgesic consumption first 8 hours, first 24 hours, 24-48 hours, 48 hours to 1 week and last week at 6 weeks after surgery. Total opioid and analgesic consumption first 8 hours, first 24 hours, 24-48 hours, 48 hours to 1 week and last week at 6 weeks after surgery.
Duration of motoric and sensoric block from peripheral nerve block (needle out). Duration of motoric and sensoric block from peripheral nerve block (needle out).
Time from needle out to first rescue analgesic Time from needle out to first rescue analgesic
Quality of sleep, work ability, social life and cognitive function the first night, 48 hours, 3 days, 7 days and 6 weeks after surgery (Likert scale). Quality of sleep, work ability, social life and cognitive function the first night, 48 hours, 3 days, 7 days and 6 weeks after surgery (Likert scale).
Number of patients answering yes to the question: Do you have bothersome pain? Number of patients answering yes to the question: Do you have bothersome pain?
The type of pain experienced at block resolution (heat, cold, burning, prickly, tingling, itchy, squeezing). The type of pain experienced at block resolution (heat, cold, burning, prickly, tingling, itchy, squeezing).
Satisfaction with pain treatment (yes/no) Satisfaction with pain treatment (yes/no)
Sensory and motor test of adequate nerves after peripheral nerve block before surgery and 1 hour after surgery. Sensory and motor test of adequate nerves after peripheral nerve block before surgery and 1 hour after surgery.
Was the nerve block adequate for surgery (yes/no) Was the nerve block adequate for surgery (yes/no)
Trial Locations
- Locations (1)
Oslo University Hospital HF
🇳🇴Oslo, Norway
Oslo University Hospital HF🇳🇴Oslo, NorwayAnette AasenSite contact+4722119690anette.aasen@medisin.uio.no