Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures

Nordsjaellands Hospital

Status and phase: Completed; Phase 3

Conditions: Distal Radius Fractures; Ropivacaine; Lidocaine; Colles' Fracture; Closed Reduction of Fracture and Application of Plaster Cast; Fracture Dislocation

Treatments: Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06379490

2024-510572-20-00

P-2023-296 (Other Identifier)

CTA no: 2024-510572-20-00

Details and patient eligibility

About

To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who have given written informed consent to participate in the study after having understood it, as well as:

• Having a distal radius fracture requiring closed reduction

Exclusion criteria

Patients who meet one or more of the following criteria will be excluded from participating in the study:

• BMI > 40 kg/m2
• Weight < 50 kg
• Age < 18 years
• American Society of Anesthesiologists (ASA) physical status classification system grade >3
• Allergy to experimental drugs
• Patients who cannot cooperate with the examinations or treatment
• Patients who do not understand or speak Danish
• Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

67 participants in 3 patient groups

Ropivacaine 5 mg/ml

Active Comparator group

Description:

30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once)

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution

Ropivacaine 2 mg/ml

Experimental group

Description:

30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once)

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Lidocaine 10 mg/ml

Experimental group

Description:

30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once)

Treatment:

Drug: Lidocaine epinephrine