The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction

NCT ID: NCT01212666

Last Updated: 2012-09-11

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

Brief Summary

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The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Keywords

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Adductor Canal Block (ACB) Anterior Cruciate Ligament (ACL) Reconstruction Saphenous nerve Pain Ultrasound block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Adductor-Canal-Block, Ropivacain

25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.

Group Type EXPERIMENTAL

Ropivacain

Intervention Type PROCEDURE

Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

Adductor Canal Block, Placebo (saline)

25 patients. ACB. 30 mL Saline. Ultrasound-guided application.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type PROCEDURE

Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Interventions

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Ropivacain

Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

Intervention Type PROCEDURE

Saline

Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Intervention Type PROCEDURE

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* 18-70 years
* Reconstruction of Anterior Cruciate Ligament
* Written consent
* ASA I-II
* BMI 19-35

Exclusion Criteria

* Unable to communicate in Danish
* Allergic reactions toward drugs used in the trial
* Pregnancy
* Abuse of alcohol/drugs
* Daily opioid intake
* Infection at injection site
* Can not be mobilised to 5 meters of walk; pre-surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Malene Espelund

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malene Espelund, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Locations

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Department of Anaesthesiology, Glostrup University Hospital

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

References

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Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.

Reference Type DERIVED
PMID: 23549123 (View on PubMed)

Other Identifiers

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SM1-ME-10

Identifier Type: -

Identifier Source: org_study_id