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

NCT ID: NCT02172729

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACB with lidocaine 5 mg/ml

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

Group Type EXPERIMENTAL

Adductor canal block with 20 ml lidocaine, single bolus

Intervention Type DRUG

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

ACB with lidocaine 15 mg/ml

Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus

Group Type EXPERIMENTAL

Adductor canal block with 20 ml lidocaine, single bolus

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA 1
* Body mass index 18-25

Exclusion Criteria

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Pia Jaeger

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pia Jæger, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Jørgen B Dahl, Professor

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 27537926 (View on PubMed)

Other Identifiers

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2014-001752-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM1-PJ-14

Identifier Type: -

Identifier Source: org_study_id