ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Information source: Seoul Medical Center
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Anesthesia; Total Knee Replacement Arthroplasty
Intervention: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine (Drug); intrathecal bupivacaine 7 mg with 100 mcg of epinephrine (Drug); intrathecal bupivacaine 8 mg with 100 mcg of epinephrine (Drug); intrathecal bupivacaine 9 mg with 100 mcg of epinephrine (Drug); intrathecal bupivacaine 10 mg with 100 mcg of epinephrine (Drug); intrathecal bupivacaine 11 mg with epinephrine 100 mcg (Drug); intrathecal bupivacaine 6 mg with 200 mcg of epinephrine (Drug); intrathecal bupivacaine 7 mg with 200 mcg of epinephrine (Drug); intrathecal bupivacaine 8 mg with 200 mcg of epinephrine (Drug); intrathecal bupivacaine 9 mg with 200 mcg of epinephrine (Drug); intrathecal bupivacaine 10 mg with 200 mcg of epinephrine (Drug); intrathecal bupivacaine 11 mg with 200 mcg of epinephrine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Seoul Medical Center Official(s) and/or principal investigator(s):
Won Ho Kim, M.D., Principal Investigator, Affiliation: Seoul Medical Center
Summary
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.
Clinical Details
Official title: ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Primary outcome: the success of anesthesia
Secondary outcome: Adverse effects of the various intrathecal bupivacaine dose
Detailed description:
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Seoul Medical Center, Seoul 135-740, Korea, Republic of
Additional Information
Starting date: December 2009
Last updated: January 29, 2012
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