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

NCT ID: NCT01264575

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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

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Spinal Anesthesia Total Knee Replacement Arthroplasty

Keywords

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spinal anesthesia intrathecal bupivacaine epinephrine ED50 ED95

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BPV6E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

BPV7E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

BPV8E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

BPV9E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

BPV10E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

BPV11E1

Group Type EXPERIMENTAL

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

Intervention Type DRUG

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

BPV6E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

BPV7E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

BPV8E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

BPV9E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

BPV10E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

BPV11E2

Group Type EXPERIMENTAL

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Interventions

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intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

Intervention Type DRUG

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

Intervention Type DRUG

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Intervention Type DRUG

Other Intervention Names

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marcaine epinephrine marcaine epinephrine marcaine epinephrine marcaine epinephrine marcaine epinephrine marcaine epinephrine bupivacaine epinephrine bupivacaine epinephrine bupivacaine epinephrine bupivacaine epinephrine bupivacaine epinephrine bupivacaine epinephrine

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Ho Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul Medical Center

Locations

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Seoul Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC-2010-12-18

Identifier Type: -

Identifier Source: org_study_id