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Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

NCT ID: NCT04574154

Last Updated: 2021-12-09

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

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-08-21

Brief Summary

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THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FIB

ultrasound guided Fascia Iliaca Block

Group Type EXPERIMENTAL

FIB

Intervention Type PROCEDURE

FIB with ultrasound: Ropivacaine 0.5% 40 ml

spinal anesthesia

Intervention Type PROCEDURE

bupivacaine 0,5% 2.2 ml

ESPB

ultrasound guided Erector Spinae Plane Block

Group Type EXPERIMENTAL

ESPB

Intervention Type PROCEDURE

ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml

spinal anesthesia

Intervention Type PROCEDURE

bupivacaine 0,5% 2.2 ml

Interventions

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FIB

FIB with ultrasound: Ropivacaine 0.5% 40 ml

Intervention Type PROCEDURE

ESPB

ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml

Intervention Type PROCEDURE

spinal anesthesia

bupivacaine 0,5% 2.2 ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary THR
* informed consent

Exclusion Criteria

* allergies to study drugs
* spinal anesthesia contraindicated
* kidney failure
* epilepsy, psychiatric disease, neurologic deficits
* revision surgery
* neuropathies in the lumbar area
* no informed consent
* pregnancy
* alcohol/opioid abuse
* emergency surgery/intensive care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papa Giovanni XXIII Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dario Bugada

MD PhD, principal investigator, attending anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aast Papa Giovanni Xxiii

Bergamo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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191-19000

Identifier Type: -

Identifier Source: org_study_id