NCT01264575

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Seoul Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Spinal Anesthesia
• Total Knee Replacement Arthroplasty

Interventions

Type	Name	Description
DRUG	intrathecal bupivacaine 6 mg with 100 mcg of epinephrine	intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
DRUG	intrathecal bupivacaine 7 mg with 100 mcg of epinephrine	intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
DRUG	intrathecal bupivacaine 8 mg with 100 mcg of epinephrine	intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
DRUG	intrathecal bupivacaine 9 mg with 100 mcg of epinephrine	intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
DRUG	intrathecal bupivacaine 10 mg with 100 mcg of epinephrine	intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
DRUG	intrathecal bupivacaine 11 mg with epinephrine 100 mcg	intrathecal bupivacaine 11 mg with epinephrine 100 mcg
DRUG	intrathecal bupivacaine 6 mg with 200 mcg of epinephrine	intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
DRUG	intrathecal bupivacaine 7 mg with 200 mcg of epinephrine	intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
DRUG	intrathecal bupivacaine 8 mg with 200 mcg of epinephrine	intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
DRUG	intrathecal bupivacaine 9 mg with 200 mcg of epinephrine	intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
DRUG	intrathecal bupivacaine 10 mg with 200 mcg of epinephrine	intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
DRUG	intrathecal bupivacaine 11 mg with 200 mcg of epinephrine	intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-12-22
• Last updated: 2012-01-31

Locations

1 site across 1 country: South Korea