Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery

NCT ID: NCT02056145

Last Updated: 2014-07-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-08-31

Brief Summary

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Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Detailed Description

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Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.

Conditions

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-Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.

Group Type PLACEBO_COMPARATOR

LFCNB

Intervention Type PROCEDURE

LFCNB - Normal Saline solution 10 cc

FNB

Intervention Type PROCEDURE

FNB - Normal saline solution 10 cc

Group 2

Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.

Group Type ACTIVE_COMPARATOR

LFCNB

Intervention Type PROCEDURE

LFCNB - Normal Saline solution 10 cc

FNB

Intervention Type PROCEDURE

FNB - Chirocaine 0.25%, 20 cc

Group 3

Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.

Group Type ACTIVE_COMPARATOR

LFCNB

Intervention Type PROCEDURE

LFCNB - Chirocaine 0.25%, 20 cc

FNB

Intervention Type PROCEDURE

FNB - Chirocaine 0.25%, 20 cc

Interventions

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LFCNB

LFCNB - Normal Saline solution 10 cc

Intervention Type PROCEDURE

FNB

FNB - Normal saline solution 10 cc

Intervention Type PROCEDURE

LFCNB

LFCNB - Chirocaine 0.25%, 20 cc

Intervention Type PROCEDURE

FNB

FNB - Chirocaine 0.25%, 20 cc

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary hip arthroplasty with posterolateral approach.

Exclusion Criteria

* Known allergy to levobupivacaine and / or piritramide
* Known neurological disorders or peripheral neuropathies
* Existing drug or alcohol abuse
* Chronic use of pain medication (\> started 3 months ago) not related to the hip suffering
* Coagulopathy (international normalized ratio) \> 1.4
* Thrombocytopenia \<70,000 platelets,
* Dementia
* Pregnancy
* Local infection hip
* Hepatic and / or renal impairment
* BMI\> 45.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZ Antwerpen

Ethische Comité UZ Antwerpen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan TEMURZIEV, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Antwerp University Hospital

Locations

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AZ Sint Augustinus

Wilrijk, Antwerpen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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11/36/241

Identifier Type: -

Identifier Source: org_study_id

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