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The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark.
Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections. |
|
| Control group | Active Comparator | Haematoma block with local anaesthetics i.e. lidocaine with adrenaline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided brachial plexus block | Procedure | The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative proportion of patients with distal radius fracture surgery | 90 days after closed reduction |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of treatment related complications | loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries (including skin injuries) related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment (including compression), pneumothorax, allergic reaction, new bone or joint injury (e.g. dislocation or fracture) after the closed reduction and/or pulmonary embolism |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction | The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. | 0-12 hours, 90 days and 12 months after closed reduction |
| Maximum pain in the affected wrist within the first 24 hours after closed reduction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecilie D Harwood, MD, PhD-fellow | Contact | 48 29 20 12 | +45 | cecilie.dupont.harwood.01@regionh.dk |
| Anders K Nørskov, MD, PhD | Contact | 48 29 74 59 | +45 | anders.kehlet.noerskov@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Cecilie D Harwood, MD, PhD-fellow | Copenhagen University Hospital - North Zealand | Principal Investigator |
| Anne-Sofie Jellestad, MD, PhD-fellow | Copenhagen University Hospital - North Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - North Zealand Hillerød | Recruiting | Hillerød | Capital Region | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40633950 | Derived | Dupont Harwood C, Jellestad AL, Bahuet AR, Knudsen RL, Andersen LC, Mathiesen O, Asko Andersen J, Jakobsen JC, Rothe C, Jorgensen CC, Viberg B, Brorson S, Brabrand M, Gundtoft PH, Terndrup M, Lange KHW, Lundstrom LH, Norskov AK. Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial - a protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Jul 8;15(7):e099954. doi: 10.1136/bmjopen-2025-099954. |
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Due to the nature of the intervention, it is unfeasible to blind the patients, the doctor who performs the brachial plexus nerve block and the doctor who performs the standard care and the closed reduction. As a result, data on patient evaluated outcomes, i.e. maximum pain score during closed reduction; maximum pain within the first 24 hours after closed reduction; pain at rest; discomfort related to the anaesthetic procedure; overall satisfaction with the treatment; PRWE; DASH; EQ-5D-5L; and data on the closed reduction, i.e. number of attempts used for closed reduction and difficulty of closed reduction of the fracture, will be reported unblinded. Importantly, other caregivers and all outcome assessors are blinded, including the doctor who evaluate the radiographic results and assess the need for surgery, as well as all personnel involved in the subsequent outcome evaluations.
| Haematoma Block | Procedure | Participants will receive no peripheral nerve block and receive a haematoma block, with or without supplemental sedation and/or systemic analgesia for the closed reduction according to local guidelines and clinical practices |
|
| 90 days after closed reduction |
| Patient Rated Wrist Evaluation (PRWE) | The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire | 90 days after closed reduction |
| Maximum pain score in the affected wrist during closed reduction(s) | The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. If the patient has the closed reduction performed more than one time, the patient will be asked to report the worst pain experienced during all the attempts of a closed reduction. | 0-12 hours after the closed reduction |
| Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction | The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. | 0 -24 hours after closed reduction |
The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable. |
| 24-36 hours after the closed reduction. |
| Proportion of patients with complex regional pain syndrome (CRPS) | CRPS is defined according to the Budapest Criteria | 90 days and 12 months after closed reduction |
| Disabilities of the Arm, Shoulder, and Hand (DASH) score | DASH-score is calculated from the Danish-validated translation of the DASH questionnaire | 90 days and 12 months after closed reduction |
| Patient Rated Wrist Evaluation (PRWE) | PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire | 12 months after closed reduction |
| Quality of life (EQ-5D-5L) score | The Danish translation of the EQ-5D-5L questionnaire is used and the EQ-5D-5L-score is calculated based on the Danish EQ-5D-5L value set | 90 days and 12 months after closed reduction |
| Number of attempts used for closed reduction | Immediately after closed reduction |
| Difficulty of closed reduction of the fracture | The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult) | Immediately after closed reduction |
| Discomfort related to the anaesthetic procedure | The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable | 0-12 hours after closed reduction |
| Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia | The overall satisfaction is a patient-reported outcome on a numeric rating scale from 0-10; 0=very unsatisfied, 10=very satisfied. When evaluating the treatment, the patient is specifically asked to include all elements of the treatment including: the anaesthetic (procedure and following effects), the experience during the closed reduction and the pain and general sensation in the arm/wrist in the first 24 hours after the treatment commencement. | 24 hours after closed reduction |
| Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction) | The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. | 10-14 days after closed reduction |
| Proportion of individual complications in the composite secondary outcome | 90 days after closed reduction |
| Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function | A SAE is defined as an adverse event that leads to the following incidents:
Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE. | Within 90 days after closed reduction |
| Proportion of patients having one or more adverse events (AEs) | An AE is defined as any harmful and unintended event, sign, or symptom, that appear during the trial period, regardless of whether this AE is considered related to the treatment or not. | Within 24 hours after closed reduction |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000072039 | Fracture Dislocation |
| D003100 | Colles' Fracture |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D011885 | Radius Fractures |
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