The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01261078

Enrollment

Registered

2010-12-16

Start date

2010-12-31

Completion date

2011-07-31

Last updated

2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia

Keywords

intrathecal epinephrine, duration of anesthesia, quality of anesthesia, intrathecal fentanyl

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.

Interventions

DRUGPlacebo

intrathecal 8 mg of bupivacaine only

DRUGepinephrine 25

intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

DRUGEpinephrine 50

intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

DRUGepinephrine 100

intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

DRUGEpi 200

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the sensory level of spinal anesthesia, the quality of intraoperative analgesia	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026