NCT03749174|Completed
Radius Fracture Anesthesia and Rehabilitation (RADAR)
RADAR
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RADAR
Sponsor study identifier
interventional
120
1 country
1
Study Start
September 3, 2018
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
June 20, 2022
Actual (reported)Distal fracture of the radial bone is the commonest fracture and is also connected to osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer that than the actual trauma pain. If long acting local anesthetics are used this will occur during night time and many patients will go to the emergency room for pain treatment. Short acting local anesthetics may make it possible to treat patients pain in-house prior to leaving the hospital. In this study
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2018
Actual (reported)September 3, 2018
Actual (reported)November 21, 2018
Actual (reported)July 1, 2020
Actual (reported)June 20, 2022
Actual (reported)Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group.
Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
72 hours
Quality of Recovery; difference in sum median and its five domains of QoR-15 score at baseline, 24 hours, 72 hours and 7 days after surgery between the two groups cast and orthosis/brace. - Anesthesiology part 2
Quality of Recovery scale 15 assessment
1st three postoperative days
Post surgery arm function - Occupational therapist
Influence of immobilization by plaster or orthosis/brace
12 months
Post surgery opioid requirement - Anesthesiology part
day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
Perioperative time events - Anesthesiology part
perioperatively
Postoperative Nausea and Vomiting - Anesthesiology part
up to 72 hours post surgery
Unplanned health care contact - Anesthesiology part
1st postoperative week
Post surgery arm status 1 - Occupational therapist
12 months
Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.
Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively
Patients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
SahlgrenskaUH
Mölndal, VGR, 43180, Sweden
Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
Blomstrand J, Sellbrant I, Nellgard B, Karlsson J, Fagevik Olsen M, Kjellby Wendt G. Removable brace is as good as plaster cast after surgically treated distal radius fracture - a randomised controlled study of pain and wrist function. J Orthop Surg Res. 2025 Jul 21;20(1):691. doi: 10.1186/s13018-025-06097-0.
Bengt Nellgard, MD PhD
Göteborg University
120 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2018
First Posted
November 21, 2018
Study Start
September 3, 2018
Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation
Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),
Contact the study team to confirm eligibility.
Sellbrant I, Karlsson J, Jakobsson JG, Nellgard B. Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study. BMC Anesthesiol. 2021 Nov 9;21(1):273. doi: 10.1186/s12871-021-01499-z.
Primary Completion
July 1, 2020
Actual (reported)Study Completion
June 20, 2022
Actual (reported)Last Updated
October 27, 2022
Record last verified: 2022-10
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