The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

July 19, 2011 updated by: Seoul Medical Center

The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

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:

  • 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

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
PLACEBO_COMPARATOR: Placebo
8 mg bupivacaine only
Drug: Placebo
intrathecal 8 mg of bupivacaine only
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 15 minutes

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, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (ESTIMATE)

December 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2010-12-05

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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