Anesthesia; Adverse EffectNINONCT05868642
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT
A study testing subarachnoid block in people with Anesthesia; Adverse Effect and Anesthesia, Local, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Anesthesia; Adverse Effect, Anesthesia, Local
- What is being tested?
- subarachnoid block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2018to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- baseline SBP < 100 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
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
Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia
Read the 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.
- Conditions
- Anesthesia; Adverse Effect, Anesthesia, Local
- Being tested
- subarachnoid block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subarachnoid blockProcedure or surgery
subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| T group | Experimental | 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) Receives: Procedure: subarachnoid block |
| S group | Active comparator | levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection Receives: Procedure: subarachnoid block |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBP change
SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour
Measured: 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start25 Jun 2018
- Primary completion25 May 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- battista borghi, professor, Principal investigator, isituto ortopedico rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868642
- Sponsor's protocol ID
- 0000440
- Acronym
- NINO
- Status last verified
- May 2023
- First submitted
- 13 May 2018
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05868642
- Acronym / sponsor ID
- NINO / 0000440
- Conditions
- Anesthesia; Adverse Effect, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T group | Experimental | Procedure: subarachnoid blockSubaracnhoid 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) |
| S group | Active comparator | Procedure: subarachnoid blocklevobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- baseline SBP < 100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subarachnoid blocksubarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty | Procedure or surgery | S group, T group |
Primary outcome
SBP change
Time frame: 60 minute
SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
battista borghi, professor principal investigator
isituto ortopedico rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subarachnoid block in people with Anesthesia; Adverse Effect and Anesthesia, Local, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBP change (time frame: 60 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.