Skip to main content
OpenTrials
Completed

NCT Number: NCT02172729

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1
  • Body mass index 18-25

Exclusion criteria

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

Treatment and study plan

Adductor canal block with 20 ml lidocaine, single bolus

Drug

Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml

Primary outcomes

  1. Duration of sensory block assessed with pinprick.

    Time frame: 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 outcomes

  1. Duration of sensory block assessed by heat pain detection threshold

    Time frame: 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.

  2. Duration of sensory block assessed by warmth detection threshold

    Time frame: 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.

  3. Duration of sensory block assessed by pain during 1 minute of warmth stimulation

    Time frame: 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.

  4. Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation

    Time frame: 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.

  5. Duration of sensory block assessed by cold sensation with an alcohol swab

    Time frame: 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.

  6. Duration of motor block assessed as maximum voluntary isometric contraction.

    Time frame: 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.

  7. Time to onset of sensory block assessed by pinprick.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.