The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography

NCT02344589 | Completed Phase 4 DMC

• 1 other identifier: SM-UG-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to investigate which components of the quadriceps femoris muscle are affected following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml lignocaine 1%) as an active comparative will be used for model control. Further, we want to investigate the effect of volume on motor block. This will be evaluated by measuring the Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.

Conditions

Knee Arthroplasty, Total

Keywords

ACB; Adductor Canal Block; Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

• Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value.

  vEMG=voluntary electromyography

  one hour post-block

Secondary Outcomes (6)

• • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.

  one hour post block

• • Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value

  one hour post-block

• • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value.

  one hour post-block

• • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.

  one hour post-block

• • Association between volume and MVIC. MVIC expressed as a percentage of the pre-block value.

  one hour post-block

Study Arms (5)

ACB 10

EXPERIMENTAL

ACB in right leg with 10ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3

Drug: Lidocaine

ACB 20

EXPERIMENTAL

ACB in right leg with 20ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3

Drug: Lidocaine

ACB 30

EXPERIMENTAL

ACB in right leg with 30ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3

Drug: Lidocaine

FNB

ACTIVE COMPARATOR

FNB in left leg with 20ml of lidocaine 10mg/ml on day 1. Unblinded arm, used for model control

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

ACB in left leg with 30ml of isotonic saline on day 2. Unblinded arm used for model control

Drug: Saline

Interventions

Lidocaine DRUG

used for the active blocks

Also known as: lignocaine

ACB 10; ACB 20; ACB 30; FNB

Saline DRUG

used for the placebo-block

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
• ASA 1
• Male
• BMI 18-30
• Physical exercise 1-3 hours/week

You may not qualify if:

• Subjects who cannot cooperate with the study.
• Subjects who cannot understand or speak Danish.
• Subjects with allergy to the medicines used in the study.
• Subjects suffering from alcohol and/or drug abuse - based on the investi-gator's opinion.
• Pathology or previous surgery or trauma to the lower limb.
• Intense exercise 24 h before the tests
• Intake of any analgesics 24 h prior to baseline measurements.

Sponsors & Collaborators

• Ulrik Grevstad: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ulrik Grevstad, MD

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

DK (1)