Radius Fracture Anesthesia and Rehabilitation (RADAR) (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

Study Overview

• Status: Completed
• Conditions: Radial Fracture
• Intervention / Treatment: Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • VGR
    • Molndal, VGR, Sweden, 43180
      • SahlgrenskaUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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: 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: Long acting anesthetic block/plaster; Short acting anesthetic block/plaster; Short acting anesthetic block/orthosis; 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: 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: Long acting anesthetic block/plaster; Short acting anesthetic block/plaster; Short acting anesthetic block/orthosis; 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 orthosis for postoperative immobilisation	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: Long acting anesthetic block/plaster; Short acting anesthetic block/plaster; Short acting anesthetic block/orthosis; 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: 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: Long acting anesthetic block/plaster; Short acting anesthetic block/plaster; Short acting anesthetic block/orthosis; General Anesthesia and plaster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours
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	1st three postoperative days
Post surgery arm function - Occupational therapist	Influence of immobilization by plaster or orthosis/brace	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post surgery opioid requirement - Anesthesiology part	daily opioid requirement mg dose	day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
Perioperative time events - Anesthesiology part	Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay	perioperatively
Postoperative Nausea and Vomiting - Anesthesiology part	Any experience of PONV	up to 72 hours post surgery
Unplanned health care contact - Anesthesiology part	any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.	1st postoperative week
Post surgery arm status 1 - Occupational therapist	Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,	12 months
Post surgery arm status 2 - Occupational therapist	Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength	12 months
Post surgery arm status 3 - Occupational therapist	Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.	12 months

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Bengt Nellgard, MD PhD, Göteborg University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): June 20, 2022

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Recovery; Postoperative pain; Brace; Orthosis; Plaster; Cast; Anesthetic; Radial fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: RADAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No