Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers

Overview

To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2013

Interventions

  • Procedure: Adductor canal block with ropivacaine 0.1%
    • US-guided adductor canal block

Arms, Groups and Cohorts

  • Experimental: 30 ml
    • 30 ml ropivacaine 0.1%, single bolus
  • Experimental: 10 ml
    • 10 ml 0.1% ropivacaine, single bolus

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with reduced quadriceps strength
    • Time Frame: 0.5 to 6 hours post block
    • The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.

Secondary Measures

  • Quadriceps strength in percentage of baseline
    • Time Frame: 2, 3 and 4 hours post block
    • The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, assessed as percentage of the baseline value.
  • Quadriceps strength calculated as AUC
    • Time Frame: 30 minutes to 6 hours post block
    • The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle calculated as “area under the curve” (AUC)
  • Modified 30-second Chair Stand test
    • Time Frame: 2 and 4 hours post block
    • The difference between the pre block value and the post block value in the modified 30-second Chair Stand test performed on one leg, between the two volumes.
  • VAS pain scores during warmth stimulation
    • Time Frame: Mean value for the periode 30 minutes – 6 hours post block
    • The difference between the two volumes in VAS pain score during warmth stimulation.

Participating in This Clinical Trial

Inclusion Criteria

  • 18-30 years – Men – ASA 1 – Body Mass Index 18-25 Exclusion Criteria:

  • Allergy to study medication – Earlier trauma or surgery to the lower limb – Diabetes Mellitus

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pia Jaeger, Principal Investigator – Rigshospitalet, Denmark
  • Overall Official(s)
    • Pia Jaeger, MD, Principal Investigator, Rigshospitalet, Denmark

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