Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block

Surgery Clinical Trial

Official title:

The Effect of Combining Lidocaine and Ropivacaine on the Duration and Onset Time of an Ultrasound-guided Infraclavicular Brachial Plexus Nerve Block. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381622
• Other study ID #: CTA no: 2023-510028-63-00
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2024
• Est. completion date: September 3, 2024

Study information

• Verified date: April 2024
• Source: Nordsjaellands Hospital
• Contact: Lars H. Lundstrøm, PhD
• Phone: 48296512
• Email: lars.hyldborg.lundstroem.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: September 3, 2024
• Est. primary completion date: August 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient who have given written informed consent to participate in the study, after having understood it

Inclusion Criteria:

• Scheduled for non-acute hand surgery in regional anesthesia
• Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint

Exclusion Criteria:

• BMI > 40 kg/m2
• Weight < 60 kg
• Age < 18 years
• 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 surgery is required

Related Conditions & MeSH terms

• Anesthesia, Local
• Brachial Plexus Block
• Forearm Fracture
• Nerve Block
• Surgery

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine)
• Lidocaine epinephrine
20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
• Ropivacaine 0.75% Injectable Solution
20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine)

Locations

Country	Name	City	State
Denmark	Nordsjælland Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity at pain breakthrough	Via Numeric Rating Scale (NRS) 0 - 10 (0 = no pain; 10 = worst pain imaginable)	At pain breakthrough until a maximum of 24 hours after performed block.
Other	Duration of maximum pain intensity after the blockade has ended	Duration in hours:minutes	After the blockade has ended until a maximum of 24 hours after performed block.
Other	Occurence of adverse events (AE) and serious adverse events (SAE)	Based on phone interviews and medical records	Follow up after 24 hours and 30 days
Other	Failed blockade	A block is viewed upon as failed if complete sensory block has not been achieved within 45 minutes or if supplemental local anaesthetic is needed before or during surgery.	Evaluated 30 minutes after completed surgery
Other	The patient's experience of the treatment (patient satisfaction)	Via Numeric Rating Scale (NRS) 0 - 10 (0 = very dissatisfied; 10 = very satisfied)	24 hours
Primary	Total time to breakthrough pain	From the completion of the LIC block to first sensation of pain from the surgical area.	24 hours
Secondary	The onset of sensory block	From the completion of the LIC block to complete sensory blockade; Tested with refrigerator-cold glass vials.; 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 tested nerves obtaining three points on the 3-point scale (no cold sensation).; This outcome is measured until the complete block is obtained, but no longer than 45 minutes.; - If a complete sensory block is not obtained after 45 minutes, the LIC block is viewed as a failed block.	Until max 45 minutes
Secondary	Total duration of sensory blockade	From the completion of the LIC block until the ending of sensory blockade	24 hours
Secondary	Total duration of motor blockade	From the completion of the LIC block until the ending of motor blockade	24 hours
Secondary	Degree of motor blockade	Measured according to Manual Muscle Testing scale (4 point scale); At the time of complete sensory blockade (defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation)), or if complete sensory blockade is not obtained, the degree of motor blockade is tested at 45 minutes.; 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 = significant difference, movement is significantly compromised, 0 point = paralysis.	At complete sensory blockade and otherwise 45 minutes after block performance