Healthy
Conditions
Keywords
adductor canal block, healthy volunteers, US-guided peripheral nerve block, lower limb, duration, Muscle Strength, Anesthetics, Local, Sensation
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.
Interventions
DRUGAdductor canal block with 20 ml lidocaine, single bolus
Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA 1 * Body mass index 18-25
Exclusion criteria
* Allergy to study medication * Earlier trauma or surgery to lower limb * Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of sensory block assessed with pinprick. | 0-10 hours | Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of sensory block assessed by warmth detection threshold | 0-10 hours | Duration is defined as time from block performance until recovery of normal sensation (return to baseline value + 2 degrees Celsius or less from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Duration of sensory block assessed by pain during 1 minute of warmth stimulation | 0-10 hours | Duration is defined as time from block performance until recovery of normal sensation (return to baseline VAS pain scores +/-10 mm from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation | 0-10 hours | Duration is defined as time from block performance until recovery of normal sensation (return to baseline preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Duration of sensory block assessed by heat pain detection threshold | 0-10 hours | Duration is defined as time from block performance until recovery of normal sensation (+/- 2 degrees Celsius from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Duration of motor block assessed as maximum voluntary isometric contraction. | 0-10 hours | Duration is defined as time from block performance until recovery of normal muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Time to onset of sensory block assessed by pinprick. | 0-2 hours | Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour. |
| Duration of sensory block assessed by cold sensation with an alcohol swab | 0-10 hours | Duration is defined as time from block performance until recovery of normal sensation assessed at 30 and 60 minutes post block, and thereafter every hour. |
Countries
Denmark
Outcome results
None listed