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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Adductor canal block with 20 ml lidocaine, single bolus

• Registration Number: NCT02172729
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ACB with lidocaine 5 mg/ml	Adductor canal block with 20 ml lidocaine, single bolus	Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus
ACB with lidocaine 15 mg/ml	Adductor canal block with 20 ml lidocaine, single bolus	Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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.

Trial Locations

Locations (1)

Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia; 🇩🇰 Copenhagen, Denmark