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

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT05868642
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect; Anesthesia, Local	Procedure: subarachnoid block	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato
• Actual Study Start Date: Jun 25, 2018
• Actual Primary Completion Date: May 25, 2020
• Actual Study Completion Date: Jun 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SBP change [60 minute]

   SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna	BO	Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

• Principal Investigator: battista borghi, professor, isituto ortopedico rizzoli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT05868642
• Other Study ID Numbers: 0000440
• First Posted: May 22, 2023
• Last Update Posted: May 22, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 22, 2023