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

Hemodynamic Stability Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877690
• Other study ID #: Selective spinal anaesthesia
• Status: Recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Zahwa Yehya, Master
• Phone: +0201007968687
• Email: drzahwa1996[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• refusal

• Allergy to the studied drugs.

• Patients with contraindications to spinal anesthesia.

• Patients with advanced decompensated cardiac, renal, hepatic disease

• Coagulopathy or thrombocytopenia

Related Conditions & MeSH terms

• Hemodynamic Stability
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Bupivacaine 0.5% Injectable Solution
Patient will be received the drug intrathecal
• Prilocaine Hydrochloride 2% Injection
Patient will be received the drug intrathecal

Locations

Country	Name	City	State
Egypt	Assuit university	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring blood pressure both systole and diastole	When, how the chang in the baseline	75 minutes