Radius Fracture Anesthesia and Rehabilitation (RADAR)

NCT ID: NCT03749174

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2022-06-20

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

Conditions

Radial Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Long acting Supraclivicular block vs Short acting Supraclavicular block

Intervention Type: 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

Short acting anesthetic block/plaster

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

Group Type: ACTIVE_COMPARATOR

Long acting Supraclivicular block vs Short acting Supraclavicular block

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Long acting Supraclivicular block vs Short acting Supraclavicular block

Intervention Type: 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

General Anesthesia and plaster

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

Group Type: ACTIVE_COMPARATOR

Long acting Supraclivicular block vs Short acting Supraclavicular block

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Long acting anesthetic block/plaster; Short acting anesthetic block/plaster; Short acting anesthetic block/orthosis; General Anesthesia and plaster

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

• High energy trauma
• Ligament injury

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bengt Nellgård

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bengt Nellgard, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

SahlgrenskaUH

Mölndal, VGR, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 26869374 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34753423 (View on PubMed)

Other Identifiers

RADAR

Identifier Type: -

Identifier Source: org_study_id