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

January 9, 2014 updated by: Pia Jaeger, Rigshospitalet, Denmark
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0.5 to 6 hours post block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 3 and 4 hours post block
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)
30 minutes to 6 hours post block
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.
2 and 4 hours post block
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.
Mean value for the periode 30 minutes - 6 hours post block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Pia Jaeger, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2-PJ-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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