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

Knee Arthroplasty, Total Clinical Trial

Official title:

The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography: A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344589
• Other study ID #: SM-UG-14
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2015
• Last updated: January 27, 2015
• Start date: January 2015
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Description:

The ACB has a well-proven analgesic effect after TKA, but we do not know which nerves that are affected by the block. Aside being a motor nerve, the nerve to the vastus medialis of the quadriceps femoris muscle, contains the second largest sensory contribution from the femoral nerve. It is probable that some of the analgesic effect of the ACB arises from blocking this nerve.

Even though the ACB is mainly a sensory nerve block, a study in healthy volunteers showed a small decline by 8% in quadriceps muscle strength(10). It is speculated that the decline in muscle strength was caused by the spread of local anesthetic to the nerve supplying the vastus medialis of the quadriceps femoris muscle. Three out of eleven of the volunteers experienced an even larger decline of 25 % in quadriceps muscle strength. It has been argued that this decline likely was caused by a proximal spread of the local anesthetic to the femoral triangle thereby resulting in an affection of the femoral nerve. In this study, a volume of 30 ml of local anesthetic was used.

We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG recordings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) measured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electrical stimulation of the femoral nerve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

Drug:
• Lidocaine
used for the active blocks
• Saline
used for the placebo-block

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ulrik Grevstad

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• 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.	vEMG=voluntary electromyography	one hour post block	No
Secondary	• Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value	MVIC=maximum voluntary isometric contraction. (Quadriceps femoris muscle)	one hour post-block	No
Secondary	• 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.	sEMG= stimulated Electromyography	one hour post-block	No
Secondary	• 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.	sEMG= stimulated Electromyography	one hour post-block	No
Secondary	• Association between volume and MVIC. MVIC expressed as a percentage of the pre-block value.		one hour post-block	No
Secondary	Difference in proportions between ACB-groups having an affection of both the saphenous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG	For each subject a series of 5 voluntary EMG recordings during MVIC will be made to estab-lish the variability of the EMG recordings. This will be done prior to the blocks on each day resulting in 300 EMG recordings from the vastus medialis and 300 recordings from the vastus lateralis. From this variability we will establish a cut-off point (how large a decline in EMG amplitude is "synonymous" with affection of the nerve?). After the cut-off point has been established the EMG data will be presented in dichotomous form: affected/not affected	one hour post-block	No