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Completed

NCT Number: NCT03749174

Radius Fracture Anesthesia and Rehabilitation (RADAR)

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SahlgrenskaUH

Mölndal, VGR, 43180, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long acting Supraclivicular block vs Short acting Supraclavicular block

Procedure

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: Long acting anesthetic block/plaster, Short acting anesthetic block/plaster, Short acting anesthetic block/orthosis, General Anesthesia and plaster

Primary outcomes

  1. 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.

  2. 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

  3. Post surgery arm function - Occupational therapist

    Time frame: 12 months

    Influence of immobilization by plaster or orthosis/brace

Secondary outcomes

  1. 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

  2. Perioperative time events - Anesthesiology part

    Time frame: perioperatively

    Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay

  3. Postoperative Nausea and Vomiting - Anesthesiology part

    Time frame: up to 72 hours post surgery

    Any experience of PONV

  4. 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.

  5. Post surgery arm status 1 - Occupational therapist

    Time frame: 12 months

    Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,

  6. Post surgery arm status 2 - Occupational therapist

    Time frame: 12 months

    Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength

  7. 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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: RADAR

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Nov 21, 2018
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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