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

Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Anesthesia; Adverse Effect
• Intervention / Treatment: Procedure: subarachnoid block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: subarachnoid block; subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty
Active Comparator: S group; levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection	Procedure: subarachnoid block; subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP change	SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour	60 minute

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: battista borghi, professor, isituto ortopedico rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0000440

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No