Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty

NCT ID: NCT02344264

Last Updated: 2015-09-25

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS \> 40 during active 30 degrees hip flexion will be asked to participate.

Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Detailed Description

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Conditions

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Pain, Postoperative Ropivacaine Therapeutic Use Arthroplasty, Replacement, Hip

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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RP

first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml

Group Type OTHER

Ropivacaine

Intervention Type DRUG

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Saline

Intervention Type DRUG

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

PR

first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml

Group Type OTHER

Ropivacaine

Intervention Type DRUG

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Saline

Intervention Type DRUG

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Interventions

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Ropivacaine

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Intervention Type DRUG

Saline

Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).

Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.

Intervention Type DRUG

Other Intervention Names

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Naropin NaCl Placebo

Eligibility Criteria

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Inclusion Criteria

* THA within 48 hours and VAS\>40 during active 30 degrees hip flexion despite conventional pain medication.
* informed consent
* ASA 1-3
* BMI 18-40

Exclusion Criteria

* Unable to communicate in danish
* Allergic reactions toward drugs used
* Abuse of alcohol/drugs
* Unable to cooperate
* Pregnant women
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daniel Hägi-Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Daniel Hägi-Pedersen

Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel Hägi-Pedersen, Ph.D.

Role: STUDY_CHAIR

Naestved Hospital, Department of Anaesthesiology

Locations

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Department of Anaesthesiology

Næstved, Danmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2014-003730-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PROTOKOL - 001-2014 - KHTY

Identifier Type: -

Identifier Source: org_study_id

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