Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.

NCT05101291

Hip Fractures Anesthesia Hypotension Drug-Induced +1 more

COMPLETED NA

Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia in Geriatric Patients

NCT06972485

Geriatric Patient Spinal Anesthesia Hip Surgery

COMPLETED NA

Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery

NCT03843970

Hip Fractures Hemodynamic Stability

UNKNOWN PHASE4

Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients

NCT01960543

Complication of Anesthesia

COMPLETED PHASE4

Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

NCT03858465

Hip Fractures Elderly Patients Spinal Anesthesia +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. However, hypotension still occurs with continuous spinal anesthesia.

Unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side.

Our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fracture Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hypobaric

continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.

Group Type EXPERIMENTAL

continuous spinal anesthesia

Intervention Type PROCEDURE

Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.

hypobaric bupivacaine

Intervention Type DRUG

hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.

ephedrine

Intervention Type DRUG

isobaric

continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine

Group Type ACTIVE_COMPARATOR

continuous spinal anesthesia

Intervention Type PROCEDURE

Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.

isobaric bupivacaine

Intervention Type DRUG

0.5% isobaric bupivacaine

ephedrine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.