The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Placebo

8 mg bupivacaine only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intrathecal 8 mg of bupivacaine only

Epi 25

8 mg of bupivacaine mixed with 25 mcg of epinephrine

Group Type ACTIVE_COMPARATOR

epinephrine 25

Intervention Type DRUG

intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

Epi 50

8 mg of bupivacaine mixed with 50 mcg of epinephrine

Group Type ACTIVE_COMPARATOR

Epinephrine 50

Intervention Type DRUG

intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

Epi 100

8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Group Type ACTIVE_COMPARATOR

epinephrine 100

Intervention Type DRUG

intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Epi 200

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Group Type ACTIVE_COMPARATOR

Epi 200

Intervention Type DRUG

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Interventions

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Placebo

intrathecal 8 mg of bupivacaine only

Intervention Type DRUG

epinephrine 25

intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

Intervention Type DRUG

Epinephrine 50

intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

Intervention Type DRUG

epinephrine 100

intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Intervention Type DRUG

Epi 200

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Intervention Type DRUG

Other Intervention Names

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Epinephrine Epinephrine Epinephrine Epinephrine epinephrine

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No