Clinical trial NCT03749174: Radius Fracture Anesthesia and Rehabilitation (RADAR)
Official title: Radius Fracture Anesthesia and Rehabilitation (RADAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Fracture
Keywords: Radial fracture
Anesthetic
Plaster
Cast
Orthosis
Brace
Postoperative pain
Quality of Recovery
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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.
timeFrame: 72 hours
measure: 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
timeFrame: 1st three postoperative days
measure: Post surgery arm function - Occupational therapist
timeFrame: 12 months
Secondary outcomes:
measure: Post surgery opioid requirement - Anesthesiology part
timeFrame: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
measure: Perioperative time events - Anesthesiology part
timeFrame: perioperatively
measure: Postoperative Nausea and Vomiting - Anesthesiology part
timeFrame: up to 72 hours post surgery
measure: Unplanned health care contact - Anesthesiology part
timeFrame: 1st postoperative week
measure: Post surgery arm status 1 - Occupational therapist
timeFrame: 12 months
measure: Post surgery arm status 2 - Occupational therapist
timeFrame: 12 months
measure: Post surgery arm status 3 - Occupational therapist
timeFrame: 12 months
Other outcomes:
Locations:
city: Molndal
country: Sweden
facility: SahlgrenskaUH
state: VGR
Study officials:
affiliation: Göteborg University
name: Bengt Nellgard, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.