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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Adductor canal block with 20 ml lidocaine, single bolus

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACB with lidocaine 5 mg/ml; Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus	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
Experimental: ACB with lidocaine 15 mg/ml; Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Jørgen B Dahl, Professor, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: lower limb; healthy volunteers; Muscle Strength; Anesthetics, Local; duration; adductor canal block; US-guided peripheral nerve block; Sensation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SM1-PJ-14; 2014-001752-31 (EudraCT Number)