Radius Fracture Anesthesia and Rehabilitation (RADAR)
- Conditions
- Radial Fracture
- Interventions
- Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block
- Registration Number
- NCT03749174
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Understands native language
- Cognitive intact
- Fracture types AO 23..A and AO 23.C.1
- Operated within 18 days from initial trauma
- Not fulfilling inclusion criterias
- High energy trauma
- Ligament injury
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description General Anesthesia and plaster Long acting Supraclivicular block vs Short acting Supraclavicular block Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30), Long acting anesthetic block/plaster Long acting Supraclivicular block vs Short acting Supraclavicular block Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization. Short acting anesthetic block/plaster Long acting Supraclivicular block vs Short acting Supraclavicular block Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively Short acting anesthetic block/orthotic Long acting Supraclivicular block vs Short acting Supraclavicular block Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation
- Primary Outcome Measures
Name Time Method Post surgery arm function - Occupational therapist 12 months Influence of immobilization by plaster or orthosis/brace
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 1st three postoperative days Quality of Recovery scale 15 assessment
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 hours Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
- Secondary Outcome Measures
Name Time Method Post surgery arm status 2 - Occupational therapist 12 months Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Post surgery opioid requirement - Anesthesiology part day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace) daily opioid requirement mg dose
Post surgery arm status 3 - Occupational therapist 12 months Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
Post surgery arm status 1 - Occupational therapist 12 months Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Perioperative time events - Anesthesiology part perioperatively Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Postoperative Nausea and Vomiting - Anesthesiology part up to 72 hours post surgery Any experience of PONV
Unplanned health care contact - Anesthesiology part 1st postoperative week any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Trial Locations
- Locations (1)
SahlgrenskaUH
🇸🇪Molndal, VGR, Sweden