Radius Fracture Anesthesia and Rehabilitation (RADAR)

Study Overview
=================
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

Official Title
-----------------
Radius Fracture Anesthesia and Rehabilitation (RADAR)

Conditions
-----------------
Radial Fracture

Intervention / Treatment
-----------------
* Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long acting anesthetic block/plaster<br>Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization. | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block<br>* 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<br>* Other names: General Anesthesia and plaster;|
| Active Comparator: Short acting anesthetic block/plaster<br>Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block<br>* 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<br>* Other names: General Anesthesia and plaster;|
| Active Comparator: Short acting anesthetic block/orthotic<br>Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block<br>* 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<br>* Other names: General Anesthesia and plaster;|
| Active Comparator: General Anesthesia and plaster<br>Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30), | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block<br>* 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<br>* Other names: General Anesthesia and plaster;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post surgery opioid requirement - Anesthesiology part | daily opioid requirement mg dose | day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace) | 
| Perioperative time events - Anesthesiology part | Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay | perioperatively | 
| Postoperative Nausea and Vomiting - Anesthesiology part | Any experience of PONV | up to 72 hours post surgery | 
| Unplanned health care contact - Anesthesiology part | any unplanned contact with health care, emergency department visit, phone calls, GP visits etc. | 1st postoperative week | 
| Post surgery arm status 1 - Occupational therapist | Clinical evaluation of post surgery arm status by a physiotherapist including: oedema, | 12 months | 
| Post surgery arm status 2 - Occupational therapist | Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength | 12 months | 
| Post surgery arm status 3 - Occupational therapist | Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery