Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.

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Detailed Description

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52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine.

The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.

Conditions

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Total Knee Arthroplasty in Geriatric Patients Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric bupivacaine

12.5 mg of 0.5% hyperbaric bupivacaine

Group Type ACTIVE_COMPARATOR

Hyperbaric bupivacaine

Intervention Type DRUG

12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Isobaric ropivacaine

15 mg of 0.5% isobaric ropivacaine

Group Type EXPERIMENTAL

Isobaric ropivacaine

Intervention Type DRUG

15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Interventions

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Hyperbaric bupivacaine

12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Intervention Type DRUG

Isobaric ropivacaine

15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.