Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers

NCT01449097 | Completed Phase 4 DMC

• 1 other identifier: SM2-PJ-11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.

Conditions

Muscle Strength; Healthy Volunteers

Keywords

Adductor-Canal-blockade,; human volunteers,; US-guided nerve block; femoral nerve block

Outcome Measures

Primary Outcomes (1)

• the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo

  0-6 hours

Secondary Outcomes (4)

• The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block

  0-6 hours

• The difference in quadriceps muscle strength between the placebo and the femoral nerve block

  0-6 hours

• The difference in adductor muscle strength between the groups

  0-6 hours

• The difference in mobilization between the groups

  0-6 hours

Study Arms (3)

Adductor-Canal-Blockade

EXPERIMENTAL

Procedure: Adductor-Canal-Blockade

The femoral nerve block

ACTIVE COMPARATOR

Procedure: The femoral nerve block

Placebo

PLACEBO COMPARATOR

Procedure: Placebo

Interventions

Adductor-Canal-Blockade PROCEDURE

US-guided Adductor-Canal-blockade with Ropivacaine

Adductor-Canal-Blockade

The femoral nerve block PROCEDURE

US-guided femoral nerve block with ropivacaine

The femoral nerve block

Placebo PROCEDURE

US-guided Adductor-Canal-Blockade/femoral nerve block with saline

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent
• ASA 1
• BMI \> 18 og \< 25

You may not qualify if:

• Can not cooperate to the exam
• Do not speak or understand Danish
• Drug allergy
• Alcohol or drug abuse
• Daily consumption of analgetics on prescription
• Any drug intake within the last 48 hours
• Neuromuscular defects in the femoral nere, the obturator nerve or the muscles of the thigh.
• Previous surgery or trauma to the lower limb
• Diabetes Mellitus
• Intake of steroids, except steroids for inhalation
• Physical exercise within the last 24 hours prior to Day 1 and 2 of the study

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

  PMID: 23241723 DERIVED

Study Officials

• Pia Jæger, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

DK (1)