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The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

This study has been completed.
Sponsor:
Information provided by:
Seoul Medical Center
ClinicalTrials.gov Identifier:
NCT01261078
First received: December 15, 2010
Last updated: July 19, 2011
Last verified: December 2010
History of Changes
  Purpose

Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or increase the quality of anesthesia. However, there is still a controversy, and the mechanism of epinephrine is recently suggested as a modulator of pain information in the spinal cord. Therefore, the investigators try to investigate the dose sparing effect of intrathecal epinephrine for spinal anesthesia with bupivacaine.


Condition Intervention
Spinal Anesthesia
 Drug: Placebo
Drug: epinephrine 25
Drug: Epinephrine 50
Drug: epinephrine 100
Drug: Epi 200

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul Medical Center:

Primary Outcome Measures:
  • the sensory level of spinal anesthesia, the quality of intraoperative analgesia [ Time Frame: every 15 minutes ] [ Designated as safety issue: No ]
    at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.


Estimated Enrollment: 75
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
8 mg bupivacaine only
 Drug: Placebo
intrathecal 8 mg of bupivacaine only
Other Name: Epinephrine
Active Comparator: Epi 25
8 mg of bupivacaine mixed with 25 mcg of epinephrine
 Drug: epinephrine 25
intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine
Other Name: Epinephrine
Active Comparator: Epi 50
8 mg of bupivacaine mixed with 50 mcg of epinephrine
 Drug: Epinephrine 50
intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine
Other Name: Epinephrine
Active Comparator: Epi 100
8 mg of bupivacaine mixed with 0.1 mg of epinephrine
 Drug: epinephrine 100
intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine
Other Name: Epinephrine
Active Comparator: Epi 200
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
 Drug: Epi 200
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Other Name: epinephrine

Detailed Description:

For patient undergoing total knee replacement arthroplasty, patients injected intrathecally with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg with 100 mcg of epinephrine. The investigators compared the characteristics of spinal anesthesia including the quality and complication of spinal anesthesia. The researchers investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and this effect is dependent on the dose of epinephrine.

  Eligibility

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

Inclusion Criteria:

  • patient undergoing total knee replacement arthroplasty

Exclusion Criteria:

  • patient with cardiac or pulmonary disease (ASA class III or more)
  • patient undergone previous spine surgery
  • patient undergoing revised knee replacement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261078

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 M.D. Faculty anesthesiologist, Seoul Meducal Center
ClinicalTrials.gov Identifier: NCT01261078     History of Changes
Other Study ID Numbers: SMC-2010-12-05
Study First Received: December 15, 2010
Last Updated: July 19, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul Medical Center:
intrathecal epinephrine
duration of anesthesia
quality of anesthesia
intrathecal fentanyl

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Bupivacaine
Anesthetics
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
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on May 19, 2013