Radius Fracture Anesthesia and Rehabilitation (RADAR) (RADAR)
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| ClinicalTrials.gov Identifier: NCT03749174 |
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Recruitment Status :
Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : September 30, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Radial Fracture | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Intervention Model Description: | Patients are subdivided into 3 groups where one group is further subdivided into 2 groups |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Radius Fracture Anesthesia and Rehabilitation (RADAR) |
| Actual Study Start Date : | September 3, 2018 |
| Actual Primary Completion Date : | July 1, 2020 |
| Estimated Study Completion Date : | June 20, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Long acting anesthetic block/plaster
Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.
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Procedure: Long 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 Other Names:
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Active Comparator: Short acting anesthetic block/plaster
Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively
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Procedure: Long 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 Other Names:
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Active Comparator: Short acting anesthetic block/orthotic
Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation
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Procedure: Long 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 Other Names:
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Active Comparator: General Anesthesia and plaster
Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),
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Procedure: Long 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 Other Names:
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- 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. [ Time Frame: 72 hours ]Postoperative 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 2 [ Time Frame: 1st three postoperative days ]Quality of Recovery scale 15 assessment
- Post surgery arm function - Occupational therapist [ Time Frame: 12 months ]Influence of immobilization by plaster or orthosis/brace
- Post surgery opioid requirement - Anesthesiology part [ Time Frame: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace) ]daily opioid requirement mg dose
- Perioperative time events - Anesthesiology part [ Time Frame: perioperatively ]Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
- Postoperative Nausea and Vomiting - Anesthesiology part [ Time Frame: up to 72 hours post surgery ]Any experience of PONV
- Unplanned health care contact - Anesthesiology part [ Time Frame: 1st postoperative week ]any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
- Post surgery arm status 1 - Occupational therapist [ Time Frame: 12 months ]Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
- Post surgery arm status 2 - Occupational therapist [ Time Frame: 12 months ]Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
- Post surgery arm status 3 - Occupational therapist [ Time Frame: 12 months ]Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749174
| Sweden | |
| SahlgrenskaUH | |
| Molndal, VGR, Sweden, 43180 | |
| Principal Investigator: | Bengt Nellgard, MD PhD | Göteborg University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bengt Nellgard, Associate professor, Sahlgrenska University Hospital, Sweden |
| ClinicalTrials.gov Identifier: | NCT03749174 |
| Other Study ID Numbers: |
RADAR |
| First Posted: | November 21, 2018 Key Record Dates |
| Last Update Posted: | September 30, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Radial fracture Anesthetic Plaster Cast |
Orthosis Brace Postoperative pain Quality of Recovery |
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Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries |
Arm Injuries Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |