Radius Fracture Anesthesia and Rehabilitation (RADAR)

Radial Fracture Clinical Trial

— RADAR  

Official title:

Radius Fracture Anesthesia and Rehabilitation (RADAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749174
• Other study ID #: RADAR
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: June 20, 2022

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 20, 2022
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radial Fracture
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Sweden	SahlgrenskaUH	Molndal	VGR

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

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