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

Mohamed Sayed Mohamed Abbas

Status: Completed

Conditions: Spinal Anesthesia; Total Knee Arthroplasty in Geriatric Patients

Treatments: Drug: Isobaric ropivacaine; Drug: Hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02764723

MSAT-3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Hyperbaric bupivacaine

Active Comparator group

Description:

12.5 mg of 0.5% hyperbaric bupivacaine

Treatment:

Drug: Hyperbaric bupivacaine

Isobaric ropivacaine

Experimental group

Description:

15 mg of 0.5% isobaric ropivacaine

Treatment:

Drug: Isobaric ropivacaine