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CompletedNCT01261078Updated Jul 20, 2011

The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

An interventional study of Placebo and epinephrine 25 in Spinal Anesthesia, sponsored by Seoul Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-07-20.

Sponsored by Seoul Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spinal Anesthesia

Keywords

  • intrathecal epinephrine
  • duration of anesthesia
  • quality of anesthesia
  • intrathecal fentanyl
03

In context

Lead sponsor

Seoul Medical Center is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient undergoing total knee replacement arthroplasty

Exclusion criteria

Exclusion Criteria:

  • patient with cardiac or pulmonary disease (ASA class III or more)
  • patient undergone previous spine surgery
  • patient undergoing revised knee replacement
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    8 mg bupivacaine only

    Drug: Placebo

  • Active comparator
    Epi 25

    8 mg of bupivacaine mixed with 25 mcg of epinephrine

    Drug: epinephrine 25

  • Active comparator
    Epi 50

    8 mg of bupivacaine mixed with 50 mcg of epinephrine

    Drug: Epinephrine 50

  • Active comparator
    Epi 100

    8 mg of bupivacaine mixed with 0.1 mg of epinephrine

    Drug: epinephrine 100

  • Active comparator
    Epi 200

    intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

    Drug: Epi 200

Interventions

  • DrugPlacebo

    intrathecal 8 mg of bupivacaine only

    Also known as: Epinephrine

  • Drugepinephrine 25

    intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

    Also known as: Epinephrine

  • DrugEpinephrine 50

    intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

    Also known as: Epinephrine

  • Drugepinephrine 100

    intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

    Also known as: Epinephrine

  • DrugEpi 200

    intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

    Also known as: epinephrine

06

What researchers measure

Primary outcomes

  1. the sensory level of spinal anesthesia, the quality of intraoperative analgesia

    at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.

    Time frame: every 15 minutes

07

Study locations

1 site
  • Seoul Medical Center
    Seoul, 135-740, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01261078
Lead sponsor
Seoul Medical Center
First posted
Dec 16, 2010
Start date
Dec 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Jul 20, 2011

Study contacts

Won Ho Kim, M.D.
principal investigator · Seoul Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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