The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

Healthy Clinical Trial

Official title:

The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172729
• Other study ID #: SM1-PJ-14
• Secondary ID: 2014-001752-31
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2014
• Last updated: November 17, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics, Capital Region of DenmarkDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Copenhagen University Hospital GCP Unit (Data Monitoring)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• ASA 1

• Body mass index 18-25

Exclusion Criteria:

• Allergy to study medication

• Earlier trauma or surgery to lower limb

• Diabetes Mellitus

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Adductor 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

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of sensory block assessed with pinprick.	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.	0-10 hours	No
Secondary	Duration of sensory block assessed by heat pain detection threshold	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.	0-10 hours	No
Secondary	Duration of sensory block assessed by warmth detection threshold	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.	0-10 hours	No
Secondary	Duration of sensory block assessed by pain during 1 minute of warmth stimulation	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.	0-10 hours	No
Secondary	Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation	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.	0-10 hours	No
Secondary	Duration of sensory block assessed by cold sensation with an alcohol swab	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.	0-10 hours	No
Secondary	Duration of motor block assessed as maximum voluntary isometric contraction.	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.	0-10 hours	No
Secondary	Time to onset of sensory block assessed by pinprick.	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.	0-2 hours	No