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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Stability
• Intervention / Treatment: Drug: Bupivacaine 0.5% Injectable Solution; Drug: Prilocaine Hydrochloride 2% Injection

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 .

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahwa Yehya, Master; Phone Number: +0201007968687; Email: drzahwa1996@gmail.com
• Study Contact Backup: Name: Saeid Metwally; Phone Number: +0201030072161

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt
      • Recruiting
      • Assuit University
      • Contact: Assuit university; Phone Number: +209922080150; Email: Vp_grad@aun.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group M	Drug: Bupivacaine 0.5% Injectable Solution; Patient will be received the drug intrathecal; Other Names: Marcaine
Experimental: Group p	Drug: Prilocaine Hydrochloride 2% Injection; Patient will be received the drug intrathecal; Other Names: Takipril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring blood pressure both systole and diastole	When, how the chang in the baseline	75 minutes

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ekram Abdullah, Professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Bupivacaine
• Other Study ID Numbers: Selective spinal anaesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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