We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01261078
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Spinal Anesthesia Drug: Placebo Drug: epinephrine 25 Drug: Epinephrine 50 Drug: epinephrine 100 Drug: Epi 200

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty
Study Start Date : December 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. the sensory level of spinal anesthesia, the quality of intraoperative analgesia [ Time Frame: every 15 minutes ]
    at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: December 2010

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

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