Clinical trial NCT02172729: The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
Official title: The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: adductor canal block
healthy volunteers
US-guided peripheral nerve block
lower limb
duration
Muscle Strength
Anesthetics, Local
Sensation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.

The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.


Eligibility criteria: Inclusion Criteria:

* ASA 1
* Body mass index 18-25

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus

Primary outcomes:
measure: Duration of sensory block assessed with pinprick.
timeFrame: 0-10 hours
Secondary outcomes:
measure: Duration of sensory block assessed by heat pain detection threshold
timeFrame: 0-10 hours
measure: Duration of sensory block assessed by warmth detection threshold
timeFrame: 0-10 hours
measure: Duration of sensory block assessed by pain during 1 minute of warmth stimulation
timeFrame: 0-10 hours
measure: Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation
timeFrame: 0-10 hours
measure: Duration of sensory block assessed by cold sensation with an alcohol swab
timeFrame: 0-10 hours
measure: Duration of motor block assessed as maximum voluntary isometric contraction.
timeFrame: 0-10 hours
measure: Time to onset of sensory block assessed by pinprick.
timeFrame: 0-2 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jæger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Jørgen B Dahl, Professor
role: STUDY_CHAIR
References:
citation: Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Grevstad U, Siersma V, Fabritius ML, Dahl JB. Effect of Total Dose of Lidocaine on Duration of Adductor Canal Block, Assessed by Different Test Methods: A Report of Two Blinded, Randomized, Crossover Studies in Healthy Volunteers. Anesth Analg. 2016 Oct;123(4):1026-32. doi: 10.1213/ANE.0000000000001517.