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

Lidocaine Clinical Trial

Official title:

Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379490
• Other study ID #: CTA no: 2024-510572-20-00
• Secondary ID: 2024-510572-20-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 23, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Nordsjaellands Hospital
• Contact: Anders K. Nørskov, PhD
• Phone: 48 29 74 59
• Email: anders.kehlet.noerskov[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Distal Radius Fractures
• Fracture Dislocation
• Fractures, Bone
• Lidocaine
• Radius Fractures
• Ropivacaine
• Wrist Fractures

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution
30 ml of Ropivacaine 0.2% = 60 mg ropivacaine
• Lidocaine epinephrine
30 ml of Lidocaine 1% with 5 µg/ml epinephrine = 300 mg lidocaine + 150 µg epinephrine
• Ropivacaine 0.5% Injectable Solution
30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - North Zealand	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of sensory and motor blockade	Degree of sensory and motor blockade 30 and 45 minutes after block performance.; Sensory blockade assessment: A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.; A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).; Motor blockade assessment: Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, movement against resistance is possible, 2 points = a slight difference, movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 point = paralysis.; A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.	30 to 45 minutes after block performance
Other	Total duration of sensory blockade	From the completion of the LIC block until the ending of the sensory blockade.; Duration in hours:minutes.	24 hours after completed block performance
Other	Total duration of motor blockade	From the completion of the LIC block until the ending of motor blockade.; Duration in hours:minutes.	24 hours after completed block performance
Other	Pain intensity before block performance	Pain intensity measured before block performance with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))	Up to 45 minutes after inclusion interview
Other	Time to pain relief/lowest pain intensity	Time to pain relief/lowest pain intensity after block performance and before performing the closed reduction; Duration in hours:minutes	Up to 45 minutes after block performance
Other	Pain intensity during closed reduction	Pain intensity measured during closed reduction with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))	Duration of closed reduction (approx. 5 to 10 minutes)
Other	Pain intensity during cast application	Pain intensity measured during cast application with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))	Duration of cast application (approx. 5 to 10 minutes)
Other	Time to pain breakthrough after the blockade has ended	Time after block performance until pain breakthrough defined as NRS>3 (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)); Duration in hours:minutes	Up to 24 hours after block performance
Other	Maximum pain intensity after the blockade has ended	Pain intensity measured after the blockade has ended with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))	Up to 24 hours after block performance
Other	Duration of maximum pain intensity after the blockade has ended	Time period of maximum pain intensity after the blockade has ended; Duration in hours:minutes	Up to 24 hours after block performance
Other	Amount of strong painkillers consumed by patients within 24 hours after closed reduction	Amount of strong painkillers consumed by patients within 24 hours after closed reduction will be measured in 24-hour morphine equivalents (milligrams).	24 hours after completed block performance
Other	Grading of closed reduction difficulty	Grading of closed reduction difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult))	Duration of closed reduction (approx. 5 to 10 minutes)
Other	Quality of closed reduction evaluated by X-ray imaging	Quality of closed reduction evaluated by X-ray imaging using the following radiological criteria: More than 10 degrees of dorsal angulation of the articular surface of the radial in a side view as compared to perpendicular to the longitudinal axis of the radial; Ulnar variance of more than 2 mm; Articular step-off of more than 2 mm; Incongruity of the distal radioulnar joint; Loss of substance/comminuted fracture of the dorsal cortex	24 hours and 30 days after block performance
Other	Attempts used for closed reduction	Number of attempts used for closed reduction. One attempt is defined as closed reduction before X-ray control imaging.	Up to 4 hours after block application
Other	Grading of casting difficulty	Grading of casting difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult))	Duration of cast application (approx. 5 to 10 minutes
Other	The patient's experience of the treatment	The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))	Up to 24 hours after block performance
Other	Occurence of adverse events (AE) and serious adverse events (SAE)	Adverse events are defined as any harmful or unwanted events, signs, or symptoms that occur during participation in the study period.; Serious adverse events are defined as events resulting in death, a life-threatening condition, permanent disability, hospital admission, or prolonged hospital admission.; Based on phone interviews and medical records 24 hours and 30 days after the procedure.	24 hours and 30 days after block performance
Primary	Block success	The incidence of successful blockade 45 minutes after block performance.; The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves.; Sensory blockade assessment: A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.; A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).; Motor blockade assessment: Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis.; A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.; Successful blockade: • Complete sensory and motor blockade 45 minutes after block performance.	45 minutes after block performance