SahlgrenskaUH
Mölndal, VGR, 43180, Sweden
NCT Number: NCT03749174
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mölndal, VGR, 43180, Sweden
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Long acting anesthetic block/plaster, Short acting anesthetic block/plaster, Short acting anesthetic block/orthosis, General Anesthesia and plaster
Time frame: 72 hours
Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
Time frame: 1st three postoperative days
Quality of Recovery scale 15 assessment
Time frame: 12 months
Influence of immobilization by plaster or orthosis/brace
Time frame: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
daily opioid requirement mg dose
Time frame: perioperatively
Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Time frame: up to 72 hours post surgery
Any experience of PONV
Time frame: 1st postoperative week
any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Time frame: 12 months
Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Time frame: 12 months
Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Time frame: 12 months
Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
Sahlgrenska University Hospital
Other
Acronym: RADAR
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