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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514795-41-00
Enrollment
80
Registered
2025-01-15
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radius fracture

Brief summary

Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10

Detailed description

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., 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., 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., Total opioid and analgesic consumption 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)., 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)., Number of patients answering yes to the question: Do you have bothersome pain?, The type of pain experienced 6 weeks after surgery, if persistens pain (heat, cold, burning, prickly, tingling, itchy, squeezing)., Satisfaction with pain treatment (yes/no), 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)

Interventions

DRUGARCOXIA 120 mg filmdrasjerte tabletter
DRUGOxyNorm 10 mg/ml injeksjonsvæske/infusjonsvæske
DRUGoppløsning
DRUGParacet 500 mg tabletter
DRUGOxycodone Actavis 5 mg harde kapsler
DRUGARCOXIA 90 mg filmdrasjerte tabletter
DRUGOxyContin 10 mg depottabletter
DRUG5 mg/ml injeksjonsvæske

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10

Secondary

MeasureTime frame
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., 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., 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., Total opioid and analgesic consumption 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)., 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 sca

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026