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Radius Fracture Anesthesia and Rehabilitation (RADAR) (RADAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749174
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bengt Nellgard, 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

Condition or disease Intervention/treatment Phase
Radial Fracture Procedure: Short or long-acting local anesthetic vs. general anesthesia Not Applicable

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) long- (n=30) , 2) short-acing (n=60) local anesthetics in a supraclavicular blockade with ultra sound assistance, or 3) general anesthesia (n=30) to provide analgesia during the operational procedure. Patients given a blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving either postoperative plaster(n=30) or an orthotic (n=30).

Patients pain will be measured by NMR during the next-coming 7 postoperative days. Also their consumption of analgesic's will be noted by personal contact intermittently by telephone and by a pain diary. 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 Questionaire (MHQ) Oedeam will be measured and strength will be measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Short or long-acting local anesthetic vs. general anesthesia
Patients are randomized to receive either plaster or orthotic in this group
Other Names:
  • Long acting anesthetic block/plaster
  • Short acting anesthetic block/plaster
  • Short acting anesthetic block/orthotic
  • General Anesthesia and plaster

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
Procedure: Short or long-acting local anesthetic vs. general anesthesia
Patients are randomized to receive either plaster or orthotic in this group
Other Names:
  • Long acting anesthetic block/plaster
  • Short acting anesthetic block/plaster
  • Short acting anesthetic block/orthotic
  • General Anesthesia and plaster

Active Comparator: Short acting anesthetic block/orthotic
Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthotic postoperatively
Procedure: Short or long-acting local anesthetic vs. general anesthesia
Patients are randomized to receive either plaster or orthotic in this group
Other Names:
  • Long acting anesthetic block/plaster
  • Short acting anesthetic block/plaster
  • Short acting anesthetic block/orthotic
  • General Anesthesia and plaster

Active Comparator: General Anesthesia and plaster
Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),
Procedure: Short or long-acting local anesthetic vs. general anesthesia
Patients are randomized to receive either plaster or orthotic in this group
Other Names:
  • Long acting anesthetic block/plaster
  • Short acting anesthetic block/plaster
  • Short acting anesthetic block/orthotic
  • General Anesthesia and plaster




Primary Outcome Measures :
  1. Postoperative rebound pain by NPRS [ Time Frame: 24 hours ]
    Postoperative pain measured by numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain.

  2. Post surgery arm function [ Time Frame: 12 months ]
    Influence of immobilization by plaster or orthonic


Secondary Outcome Measures :
  1. Post surgery arm status 1 [ Time Frame: 12 months ]
    Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,

  2. Post surgery arm status 2 [ Time Frame: 12 months ]
    Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength

  3. Post surgery arm status 3 [ Time Frame: 12 months ]
    Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Bengt Nellgard, MD PhD 0046 70 6968680 bengt.nellgard@vgregion.se
Contact: Iren Sellbrant, MD 0046 709400941 iren.sellbrant@vgregion.se

Locations
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Sweden
SahlgrenskaUH Recruiting
Molndal, VGR, Sweden, 43180
Contact: Bengt M Nellgard, MD PhD    004670 6968680    bengt.nellgard@vgregion.se   
Contact: Iren j Sellbrant, MD    0046709400941    iren.sellbrant@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Bengt Nellgard, MD PhD Göteborg University
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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: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bengt Nellgard, Sahlgrenska University Hospital, Sweden:
Radial fracture
Anesthetic
Plaster
Ortotic
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents