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

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.

Conditions

• Spinal Anesthesia
• Total Knee Replacement Arthroplasty

Interventions

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

Sponsors & Collaborators

• Seoul Medical Center

  lead OTHER

Principal Investigators

• Won Ho Kim, M.D. · Seoul Medical Center

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2011-01-31

Completion

2011-01-31

Countries

• South Korea

Study Locations