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Clinical Trials/NCT01261078
NCT01261078
Completed
Not Applicable

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

Seoul Medical Center1 site in 1 country75 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Placebo
Conditions
Spinal Anesthesia
Sponsor
Seoul Medical Center
Enrollment
75
Locations
1
Primary Endpoint
the sensory level of spinal anesthesia, the quality of intraoperative analgesia
Status
Completed
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
July 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

Placebo

8 mg bupivacaine only

Intervention: Placebo

Epi 25

8 mg of bupivacaine mixed with 25 mcg of epinephrine

Intervention: epinephrine 25

Epi 50

8 mg of bupivacaine mixed with 50 mcg of epinephrine

Intervention: Epinephrine 50

Epi 100

8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Intervention: epinephrine 100

Epi 200

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Intervention: Epi 200

Outcomes

Primary Outcomes

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.

Study Sites (1)

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