Trial | NCT02764723  Report issue

Title

Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients
Isobaric Ropivacaine 15 mg Versus Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Geriatric Patients Undergoing Total Knee Arthroplasty

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
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.
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.
Study Started
Jan 31
2013
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Jun 07
2016
Estimate

Drug Hyperbaric bupivacaine

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

Drug Isobaric ropivacaine

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

Hyperbaric bupivacaine Active Comparator

12.5 mg of 0.5% hyperbaric bupivacaine

Isobaric ropivacaine Experimental

15 mg of 0.5% isobaric ropivacaine

Criteria 

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.
No Results Posted