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Hemodynamic StabilityNCT05877690

Selective Spinal Anaesthesia With Hyperbaric Prilocain With 2%Provides Better Perioperative Hemodynamic Stability for Patients With Peripheral Vascular Disease and Cardiac Dysfunction in Lower Limb Surgery

A study testing Bupivacaine 0.5% Injectable Solution and Prilocaine Hydrochloride 2% Injection in people with Hemodynamic Stability, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

to compare the safety and efficacy of spinal anesthesia using Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% for patients with peripheral vascular disease and cardiac dysfunction. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hemodynamic Stability
What is being tested?
Bupivacaine 0.5% Injectable Solution and Prilocaine Hydrochloride 2% Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
Oct 2023to Dec 2024
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients of aged >18 years old. Both sexes, males and females.
  • The time of surgery does not exceed 75 min.
  • Compensated cardiac dysfunction
  • ASA physical status: II- IV

Who cannot join

  • refusal
  • Allergy to the studied drugs.
  • Patients with contraindications to spinal anesthesia.
  • Patients with advanced decompensated cardiac, renal, hepatic disease
  • Coagulopathy or thrombocytopenia

Trial locations and contacts

1 site in 1 country.

Zahwa Yehya, Master contact

+0201007968687

drzahwa1996@gmail.com

Saeid Metwally contact

+0201030072161

Egypt1 site, 1 recruiting
  • Assuit university

    Asyut, Assuit

    Assuit university, +209922080150, Vp_grad@aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Selective Spinal Anesthesia Using Hyperbaric Prilocaine 2% Provides Better Perioperative Hemodynamic Stability for Patients With Peripheral Vascular Disease and Cardiac Dysfunction Undergoing Lower Limb Vascular Surgery

to compare the safety and efficacy of spinal anesthesia using Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% for patients with peripheral vascular disease and cardiac dysfunction.

Read the detailed description

Spinal anesthesia has become increasingly popular for inpatient surgery, but, until recently, its use has been limited in ambulatory surgery due to the lack of a safe and licensed short-acting local anesthetic agent. An ideal intrathecal agent for ambulatory surgery should have a rapid onset of motor and sensory blockade, predictable regression within an acceptable time frame, and a low incidence of adverse effects. Hyperbaric Bupivacaine is a long-acting local anesthetic from the amide group and has a low incidence of transient neurological symptoms (TNS). Because of its pharmacological profile, the recovery of motor and sensory blocks is delayed compared to short-acting local anesthetics. The incidence of postoperative urinary retention with long-acting local anesthetics like bupivacaine is higher than with short-acting local anesthetics . Successful spinal anesthesia with low doses of bupivacaine between 5 and 10 mg without additives has been described for outpatients. The incidence of urinary retention was still 3.7-16%. Furthermore, with these low doses, block height becomes unpredictable, and the risk of block failure is high . Prilocaine is an amide local anesthetic with an intermediate duration of action after spinal administration. Recently, the old local anesthetics prilocaine was reintroduced in the market. It is available in the hyperbaric form and provides anesthesia for 75-90 min after spinal administration . Hyperbaric prilocaine 2% is increasingly used for spinal anesthesia in the ambulatory setting , as it has the advantage of faster recovery times than hyperbaric bupivacaine . We aimed to compare spinal anesthesia using hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for day case surgery in terms of sensory block, and motor block resolution times. The time for first spontaneous voiding and duration of stay in the PACU and time to home readiness.

Vascular disease and cardiac dysfunction are linked in many ways. They share common risk factors and comorbidities, and patients with systemic vascular disease often have concomitant heart disease, because the blood vessels of the heart are not spared. In patients presenting for surgery, the presence of vascular disease puts the patient at increased risk for perioperative cardiac complications, and vascular surgery poses the highest surgical risk for perioperative cardiac events.

In addition, the diseased vessels supplying critical organs depend on the perfusion pressure supplied by the heart, so any cardiac dysfunction thus amplifies the effect of poor perfusion. Patients presenting with both vascular disease and cardiac dysfunction pose a particular challenge to the anesthesiologist; although treatment goals are similar small physiologic disturbances can quickly lead to large, serious changes in clinical status.

Selective spinal anesthesia performed with a short-term hyperbaric local anesthetic could be a perfect solution, because it guarantees rapid sensory and motor block, predictable duration, and low incidence of side effects. It is usually well accepted by both patients and surgeons due to its high reliability, as it provides effective analgesia, with minimal side effects, rapid changeover times, and low costs .

Being tested
Bupivacaine 0.5% Injectable Solution, Prilocaine Hydrochloride 2% Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine 0.5% Injectable SolutionDrug

    Also called Marcaine

    Patient will be received the drug intrathecal

  • Prilocaine Hydrochloride 2% InjectionDrug

    Also called Takipril

    Patient will be received the drug intrathecal

Study groups in NCT05877690
Study groupRoleWhat they receive
Group MExperimentalNot described
Receives: Drug: Bupivacaine 0.5% Injectable Solution
Group pExperimentalNot described
Receives: Drug: Prilocaine Hydrochloride 2% Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monitoring blood pressure both systole and diastole

    When, how the chang in the baseline

    Measured: 75 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877690
Sponsor's protocol ID
Selective spinal anaesthesia
Status last verified
Mar 2023
First submitted
23 Feb 2023
Last updated
26 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine 0.5% Injectable Solution and Prilocaine Hydrochloride 2% Injection in people with Hemodynamic Stability, run by Assiut University at 1 site in Egypt.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 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 Egypt. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zahwa Yehya, Master (+0201007968687, drzahwa1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monitoring blood pressure both systole and diastole (time frame: 75 minutes). 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 26 May 2023.

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