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Radius Fracture Anesthesia and Rehabilitation (RADAR) (RADAR)

Primary Purpose

Radial Fracture

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Long acting Supraclivicular block vs Short acting Supraclavicular block
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radial Fracture focused on measuring Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SahlgrenskaUH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Long acting anesthetic block/plaster

Short acting anesthetic block/plaster

Short acting anesthetic block/orthotic

General Anesthesia and plaster

Arm Description

Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.

Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively

Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation

Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),

Outcomes

Primary Outcome Measures

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.
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
Post surgery arm function - Occupational therapist
Influence of immobilization by plaster or orthosis/brace

Secondary Outcome Measures

Post surgery opioid requirement - Anesthesiology part
daily opioid requirement mg dose
Perioperative time events - Anesthesiology part
Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Postoperative Nausea and Vomiting - Anesthesiology part
Any experience of PONV
Unplanned health care contact - Anesthesiology part
any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Post surgery arm status 1 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Post surgery arm status 2 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Post surgery arm status 3 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.

Full Information

First Posted
August 22, 2018
Last Updated
October 26, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03749174
Brief Title
Radius Fracture Anesthesia and Rehabilitation (RADAR)
Acronym
RADAR
Official Title
Radius Fracture Anesthesia and Rehabilitation (RADAR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Fracture
Keywords
Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long acting anesthetic block/plaster
Arm Type
Active Comparator
Arm Description
Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.
Arm Title
Short acting anesthetic block/plaster
Arm Type
Active Comparator
Arm Description
Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively
Arm Title
Short acting anesthetic block/orthotic
Arm Type
Active Comparator
Arm Description
Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation
Arm Title
General Anesthesia and plaster
Arm Type
Active Comparator
Arm Description
Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),
Intervention Type
Procedure
Intervention Name(s)
Long acting Supraclivicular block vs Short acting Supraclavicular block
Other Intervention Name(s)
Long acting anesthetic block/plaster, Short acting anesthetic block/plaster, Short acting anesthetic block/orthosis, General Anesthesia and plaster
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
Time Frame
72 hours
Title
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
Description
Quality of Recovery scale 15 assessment
Time Frame
1st three postoperative days
Title
Post surgery arm function - Occupational therapist
Description
Influence of immobilization by plaster or orthosis/brace
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Post surgery opioid requirement - Anesthesiology part
Description
daily opioid requirement mg dose
Time Frame
day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
Title
Perioperative time events - Anesthesiology part
Description
Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Time Frame
perioperatively
Title
Postoperative Nausea and Vomiting - Anesthesiology part
Description
Any experience of PONV
Time Frame
up to 72 hours post surgery
Title
Unplanned health care contact - Anesthesiology part
Description
any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Time Frame
1st postoperative week
Title
Post surgery arm status 1 - Occupational therapist
Description
Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Time Frame
12 months
Title
Post surgery arm status 2 - Occupational therapist
Description
Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Time Frame
12 months
Title
Post surgery arm status 3 - Occupational therapist
Description
Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Nellgard, MD PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SahlgrenskaUH
City
Molndal
State/Province
VGR
ZIP/Postal Code
43180
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26869374
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.
Results Reference
background
PubMed Identifier
34753423
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.
Results Reference
derived

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Radius Fracture Anesthesia and Rehabilitation (RADAR)

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