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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, Seoul Medical Center
ClinicalTrials.gov Identifier:
NCT01264575
First received: December 20, 2010
Last updated: January 29, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Spinal Anesthesia
Total Knee Replacement Arthroplasty
 Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg
Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Seoul Medical Center:

Primary Outcome Measures:
  • the success of anesthesia [ Time Frame: during the surgery (average two hours) ] [ Designated as safety issue: No ]
    The individual dose would be considered to be successful if no epidural supplement is required during surgery.


Secondary Outcome Measures:
  • Adverse effects of the various intrathecal bupivacaine dose [ Time Frame: during surgery (average two hours) ] [ Designated as safety issue: Yes ]
    lowest systolic blood pressure, vasopressure requirements, nausea, vomitting


Enrollment: 162
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264575

Locations
Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of, 135-740
Sponsors and Collaborators
Seoul Medical Center
Investigators
Principal Investigator: Won Ho Kim, M.D. Seoul Medical Center
  More Information

No publications provided

Responsible Party: Won Ho Kim, Staff Anesthesiologist, Seoul Medical Center
ClinicalTrials.gov Identifier: NCT01264575     History of Changes
Other Study ID Numbers: SMC-2010-12-18
Study First Received: December 20, 2010
Last Updated: January 29, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul Medical Center:
spinal anesthesia
intrathecal bupivacaine
epinephrine
ED50
ED95

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 18, 2012