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Completed

NCT Number: NCT01261078

The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

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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Key information

Conditions

Spinal Anesthesia

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Medical Center

Seoul, 135-740, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

intrathecal 8 mg of bupivacaine only

Other names: Epinephrine

epinephrine 25

Drug

intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

Other names: Epinephrine

Epinephrine 50

Drug

intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

Other names: Epinephrine

epinephrine 100

Drug

intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Other names: Epinephrine

Epi 200

Drug

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Other names: epinephrine

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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