The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

Seoul Medical Center

Status: Completed

Conditions: Spinal Anesthesia

Treatments: Drug: Epi 200; Drug: epinephrine 25; Drug: Placebo; Drug: Epinephrine 50; Drug: epinephrine 100

Study type: Interventional

Funder types: Other

Identifiers

NCT01261078

SMC-2010-12-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

75 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

8 mg bupivacaine only

Treatment:

Drug: Placebo

Epi 25

Active Comparator group

Description:

8 mg of bupivacaine mixed with 25 mcg of epinephrine

Treatment:

Drug: epinephrine 25

Epi 50

Active Comparator group

Description:

8 mg of bupivacaine mixed with 50 mcg of epinephrine

Treatment:

Drug: Epinephrine 50

Epi 100

Active Comparator group

Description:

8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Treatment:

Drug: epinephrine 100

Epi 200

Active Comparator group

Description:

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Treatment:

Drug: Epi 200