The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

NCT ID: NCT01261897

Last Updated: 2011-10-04

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

Detailed Description

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Conditions

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Postoperative Pain Knee Arthroplasty

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-Blockade with Ropivacaine

Group Type ACTIVE_COMPARATOR

Adductor-Canal-Blockade with Ropivacaine

Intervention Type PROCEDURE

US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml

Adductor-Canal-blockade with saline

Group Type PLACEBO_COMPARATOR

Adductor-Canal-blockade with saline

Intervention Type PROCEDURE

US-guided Adductor-Canal-blockade with saline

Interventions

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Adductor-Canal-Blockade with Ropivacaine

US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml

Intervention Type PROCEDURE

Adductor-Canal-blockade with saline

US-guided Adductor-Canal-blockade with saline

Intervention Type PROCEDURE

Other Intervention Names

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Naropine Postoperative pain US-guided nerve block Sham block

Eligibility Criteria

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Inclusion Criteria

* Total Knee Arthroplasty in general anaesthesia
* ASA 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of strong opioids
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Pia Jaeger

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pia Jæger, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Site Status

Countries

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Denmark

References

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Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.

Reference Type DERIVED
PMID: 22834681 (View on PubMed)

Other Identifiers

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2010-021918-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM2-PJ-10

Identifier Type: -

Identifier Source: org_study_id