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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514795-41-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low concentration | Experimental | Ropivacaine 3.75 mg/ml |
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| High concentration | Active Comparator | Ropivacaine 7.5 mg/ml |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine concentration low | Drug | Brachial plexus nerve block with ropivacaine 3.75 mg/ml |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rebound pain | 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. | From end of surgery until nerve block resolution, normally within the first 48 hours after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anette Aasen, MD, Anesthesiologist | University of Oslo and Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
All individual participant data collected during the trial, after deidentification, will be available in Norwegian at a request. In addition, the Study Protocol is a public document from application moment. Researchers who provide a methodologically sound proposal will receive access to the deidentified individual pariticipant data, to achieve aims in the approved proposal. The data will be available immediately following publication and ending 5 years following article publication. Proposals should be directed to anette.aasen@medicin.uio.no.
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Ropivacaine concentration high | Drug | Brachial plexus nerve block with ropivacaine 7.5 mg/ml |
|
| Pain score at different points of time 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 8 hours, 24 hours, 48 hours, 3 days, 7 days and 6 weeks after surgery. |
| From baseline, end of surgery, until 6 weeks after surgery. |
| Duration of moderate and strong pain | 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. | 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 | 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. | From baseline, end of surgery, until 7 days after surgery. |
| Long-lasting pain | 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. | From baseline, end of surgery, until 6 weeks after surgery. |
| Analgesic consumption 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. | From baseline, end of surgery, until 6 weeks after surgery. |
| Duration of motoric and sensoric nerve block | 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. | From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention. |
| Life quality | 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. | From baseline, end of surgery, until 6 weeks after surgery |
| Quality of long-term pain | 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. | 6 weeks after baseline, intervention and surgery. |
| Patient satisfaction | Yes or no to the question; "Are you satisfied with the pain treatment?" | From enrollment until 6 weeks after surgery |
| Block success rate | 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) | From intervention, when nerve block is performed, until 2 hours after surgery. |