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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Anesthesia; Adverse Effect; Anesthesia, Local

Treatments: Procedure: subarachnoid block

Study type: Interventional

Funder types: Other

Identifiers

NCT05868642

0000440

Details and patient eligibility

About

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

Full description

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.

Enrollment: 82 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

T group

Experimental group

Description:

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)

Treatment:

Procedure: subarachnoid block

S group

Active Comparator group

Description:

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

Treatment:

Procedure: subarachnoid block