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Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics

NCT06382220 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-11

No results posted yet for this study

Summary

Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications .

Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade.

Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration,

The aim of this study

To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people.

Conditions

  • Recruitment

Interventions

DRUG

Bupivacain

drug injection

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-23
Primary Completion
2024-07-25
Completion
2024-08-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382220 on ClinicalTrials.gov