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

January 29, 2012 updated by: Won Ho Kim, Seoul Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPV6E1
Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV7E1
Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV8E1
Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV9E1
Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV10E1
Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV11E1
Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg
intrathecal bupivacaine 11 mg with epinephrine 100 mcg
Other Names:
  • marcaine
  • epinephrine
Experimental: BPV6E2
Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV7E2
Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV8E2
Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV9E2
Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV10E2
Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV11E2
Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
Other Names:
  • bupivacaine
  • epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the surgery (average two hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects of the various intrathecal bupivacaine dose
Time Frame: during surgery (average two hours)
lowest systolic blood pressure, vasopressure requirements, nausea, vomitting
during surgery (average two hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 29, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2010-12-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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