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Completed

NCT Number: NCT01981746

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

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.

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Key information

Conditions

Muscle Strength Healthy Volunteers

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor canal block with ropivacaine 0.1%

Procedure

US-guided adductor canal block

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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