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Completed

NCT Number: NCT01264575

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

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.

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Key information

Conditions

Spinal Anesthesia Total Knee Replacement Arthroplasty

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Medical Center

Seoul, 135-740, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

Drug

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

Other names: marcaine, epinephrine

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

Drug

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

Other names: marcaine, epinephrine

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Drug

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Other names: marcaine, epinephrine

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

Drug

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

Other names: marcaine, epinephrine

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

Drug

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

Other names: marcaine, epinephrine

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

Drug

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

Other names: marcaine, epinephrine

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Drug

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Other names: bupivacaine, epinephrine

Primary outcomes

  1. the success of anesthesia

    Time frame: during the surgery (average two hours)

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

Secondary outcomes

  1. Adverse effects of the various intrathecal bupivacaine dose

    Time frame: during surgery (average two hours)

    lowest systolic blood pressure, vasopressure requirements, nausea, vomitting

Sponsors and collaborators

Lead sponsor

Seoul Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 22, 2010
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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