Skip to content

Radius Fracture Anesthesia and Rehabilitation (RADAR)

Radius Fracture Anesthesia and Rehabilitation (RADAR)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749174
Acronym
RADAR
Enrollment
120
Registered
2018-11-21
Start date
2018-09-03
Completion date
2022-06-20
Last updated
2022-10-27

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

Conditions

Radial Fracture

Keywords

Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery

Brief summary

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

Detailed description

This investigation is a joint study involving Occupational Therapist, Orthopedic surgeons and Anesthesiologist. Distal fracture of the radial bone is the commonest fracture, mainly in elder females with osteoporosis and also obesity. Normally 75% of patients are treated with plaster after fracture repositioning. The remaining 25% are operated upon. Routinely, the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer than the initial trauma pain. If long acting local anesthetics are used the blockade will be terminated during night 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 hospital discharge and thus reduce severe rebound pain. In this study patients with radial fractures are included and operated upon by a standard surgical operation with plate and screws. They will receive either 1) ultra sound guided supraclavicular block long-acting (n=30) local anesthetic , 2) ultra sound guided supraclavicular block short-acing (n=60) local anesthetics or 3) general anesthesia (n=30) to provide analgesia during the operational procedure. Patients given an ultra sound guided blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving either postoperative plaster/cast (n=30) or an orthosis/brace (n=30). Patients pain will be measured by Numeric Rating scale (0 = no pain and 10 worst possible pain) during the first 7 postoperative days. The opioid consumption will be noted by personal contact intermittently by telephone and by a pain diary until day 7. Both parametric and none-parametric analysis will be conducted. Quality of recovery will be assessed by Quality of Recovery Scale 15 at 5 occasions. Adverse effects and unplanned health care contacts will also be gathered. After 3 days the Occupational Therapist will control the patients followed by investigations at 2, 6 12 and 52 weeks. The patients will be graded the Patient rated Wrist Evaluation (PRWE) and Michigan Outcomes Questionnaire (MHQ) Edema will be measured and strength will be measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13

Interventions

PROCEDURELong acting Supraclivicular block vs Short acting Supraclavicular block

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

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Patients are subdivided into 3 groups where one group is further subdivided into 2 groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Understands native language * Cognitive intact * Fracture types AO 23..A and AO 23.C.1 * Operated within 18 days from initial trauma

Exclusion criteria

* Not fulfilling inclusion criterias * High energy trauma * Ligament injury

Design outcomes

Primary

MeasureTime frameDescription
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.72 hoursPostoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
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 21st three postoperative daysQuality of Recovery scale 15 assessment
Post surgery arm function - Occupational therapist12 monthsInfluence of immobilization by plaster or orthosis/brace

Secondary

MeasureTime frameDescription
Unplanned health care contact - Anesthesiology part1st postoperative weekany unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Post surgery arm status 1 - Occupational therapist12 monthsClinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Post surgery opioid requirement - Anesthesiology partday 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)daily opioid requirement mg dose
Post surgery arm status 3 - Occupational therapist12 monthsClinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
Post surgery arm status 2 - Occupational therapist12 monthsClinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Perioperative time events - Anesthesiology partperioperativelyPerioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Postoperative Nausea and Vomiting - Anesthesiology partup to 72 hours post surgeryAny experience of PONV

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026