Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT

NCT ID: NCT05868642

Last Updated: 2023-05-22

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2020-06-25

Brief Summary

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Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

Detailed Description

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This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

Conditions

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Anesthesia; Adverse Effect Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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T group

Subaracnhoid block levobupivacaine 0.5%, 10 mg (2 ml) via subarachnoid injection plus 1mg for each metameric level needed to achieve the T10 level sensory block (evaluation with pinprick test at 10 minute after the firts injection and at 4 minute from the second injection)

Group Type EXPERIMENTAL

subarachnoid block

Intervention Type PROCEDURE

subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

S group

levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection

Group Type ACTIVE_COMPARATOR

subarachnoid block

Intervention Type PROCEDURE

subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

Interventions

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subarachnoid block

subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI 20-40 kg/m2
* ASA 1-3
* undergoing total hip arthroplasty
* no controindications to subaracnhoid block
* able to understand and sign a written informed consensus
* METs \> o = 4

Exclusion Criteria

* baseline SBP \< 100 mmHg
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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battista borghi, professor

Role: PRINCIPAL_INVESTIGATOR

isituto ortopedico rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status

Countries

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Italy

Other Identifiers

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0000440

Identifier Type: -

Identifier Source: org_study_id

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