Closed Reduction of Fracture and Application of Plaster Cast, Colles' Fracture, Distal Radius Fractures, Fracture Dislocation, Fracture Dislocation of Upper Limb Joint
Conditions
Keywords
Lidocaine, Local anaesthesia, Regional anaesthesia, Peripheral nerve block, Brachial plexus block, Lateral infraclavicular block, Axillary plexus block, Distal radius fracture, Colles' fracture, Wrist fracture
Brief summary
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: 1. A nerve block of the arm (plexus brachialis block) 2. A haematoma block, which is the current standard anaesthesia in the emergency departments.
Interventions
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block
PROCEDUREHaematoma Block
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
Sponsors
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion criteria
* Patients who would never qualify for surgery according to local guidelines * Lack of informed consent * No Danish Central Person Register (CPR) number * Allergies to the trial medication * Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction * Open fractures (fracture-related wound requiring sutures) * Other fractures on the same extremity ((NOT including distal ulna fracture(s)) * Bilateral distal radius fractures both requiring closed reduction * Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative proportion of patients with distal radius fracture surgery | 90 days after closed reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of treatment related complications | 90 days after closed reduction | 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 |
| Patient Rated Wrist Evaluation (PRWE) | 90 days after closed reduction | The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
| Maximum pain score in the affected wrist during closed reduction(s) | 0-12 hours after the 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. 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. |
| Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction | 0 -24 hours 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EQ-5D-5L) score | 90 days and 12 months after closed reduction | 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 |
| Number of attempts used for closed reduction | Immediately after closed reduction | — |
| Difficulty of closed reduction of the fracture | Immediately after closed reduction | The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult) |
| Discomfort related to the anaesthetic procedure | 0-12 hours after closed reduction | The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable |
| Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction | 0-12 hours, 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. |
| Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction) | 10-14 days 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. |
| 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 | Within 90 days after closed reduction | A SAE is defined as an adverse event that leads to the following incidents: * Death * Life threatening injury or disease * Severe or permanent disability * Admission to the hospital or prolongation of hospitalisation Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE. |
| Proportion of patients having one or more adverse events (AEs) | Within 24 hours after closed reduction | 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. |
| Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia | 24 hours after closed reduction | 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. |
| Maximum pain in the affected wrist within the first 24 hours after closed reduction | 24-36 hours after the closed reduction. | The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable. |
| Proportion of patients with complex regional pain syndrome (CRPS) | 90 days and 12 months after closed reduction | CRPS is defined according to the Budapest Criteria |
| Disabilities of the Arm, Shoulder, and Hand (DASH) score | 90 days and 12 months after closed reduction | DASH-score is calculated from the Danish-validated translation of the DASH questionnaire |
| Patient Rated Wrist Evaluation (PRWE) | 12 months after closed reduction | PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
Countries
Denmark
Contacts
Primary ContactCecilie D Harwood, MD, PhD-fellow
Backup ContactAnders K Nørskov, MD, PhD
Outcome results
None listed