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Trial record 76 of 10344 for:    strength

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

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ClinicalTrials.gov Identifier: NCT01981746
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscle Strength Healthy Volunteers Procedure: Adductor canal block with ropivacaine 0.1% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 30 ml
30 ml ropivacaine 0.1%, single bolus
Procedure: Adductor canal block with ropivacaine 0.1%
US-guided adductor canal block

Experimental: 10 ml
10 ml 0.1% ropivacaine, single bolus
Procedure: Adductor canal block with ropivacaine 0.1%
US-guided adductor canal block




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981746


Locations
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Denmark
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Pia Jaeger, MD Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pia Jaeger, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01981746     History of Changes
Other Study ID Numbers: SM2-PJ-13
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Pia Jaeger, Rigshospitalet, Denmark:
adductor canal block
healthy volunteers
US-guided peripheral nerve block
lower limb
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents