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Clinical Trials/NCT06381622
NCT06381622
Completed
Phase 3

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

Nordsjaellands Hospital1 site in 1 country78 target enrollmentApril 18, 2024

Overview

Phase
Phase 3
Intervention
Ropivacaine 0.5% Injectable Solution
Conditions
Nerve Block
Sponsor
Nordsjaellands Hospital
Enrollment
78
Locations
1
Primary Endpoint
Total time to breakthrough pain
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 18, 2024
End Date
November 23, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nordsjaellands Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Control group: Ropi-5

30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine)

Intervention: Ropivacaine 0.5% Injectable Solution

Intervention group 1: Ropi-5+Lido-20

20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)

Intervention: Ropivacaine 0.5% Injectable Solution

Intervention group 1: Ropi-5+Lido-20

20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)

Intervention: Lidocaine epinephrine

Intervention group 2: Ropi-7.5+Lido-20

20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)

Intervention: Lidocaine epinephrine

Intervention group 2: Ropi-7.5+Lido-20

20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)

Intervention: Ropivacaine 0.75% Injectable Solution

Outcomes

Primary Outcomes

Total time to breakthrough pain

Time Frame: 24 hours

From the completion of the LIC block to first sensation of pain from the surgical area.

Secondary Outcomes

  • Total duration of sensory blockade(24 hours)
  • Total duration of motor blockade(24 hours)
  • The onset of sensory block(Until max 45 minutes)
  • Degree of motor blockade(At complete sensory blockade and otherwise 45 minutes after block performance)

Study Sites (1)

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