ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Seoul Medical Center162 enrolled

Overview

This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.

Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty. After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

162

Conditions

Spinal Anesthesia Total Knee Replacement Arthroplasty

Interventions

intrathecal bupivacaine 6 mg with 100 mcg of epinephrineDRUG

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

intrathecal bupivacaine 7 mg with 100 mcg of epinephrineDRUG

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

intrathecal bupivacaine 8 mg with 100 mcg of epinephrineDRUG

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patients with ASA class I or II scheduled for total knee replacement surgery Exclusion Criteria: * Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.

Locations (1)

Seoul Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

the success of anesthesia

The individual dose would be considered to be successful if no epidural supplement is required during surgery.

Time frame: during the surgery (average two hours)

Secondary Outcomes

Adverse effects of the various intrathecal bupivacaine dose

lowest systolic blood pressure, vasopressure requirements, nausea, vomitting

Time frame: during surgery (average two hours)

Data from ClinicalTrials.gov

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