The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261078
• Other study ID #: SMC-2010-12-05
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: July 19, 2011
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2010
• Source: Seoul Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• Placebo
intrathecal 8 mg of bupivacaine only
• epinephrine 25
intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine
• Epinephrine 50
intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine
• epinephrine 100
intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine
• Epi 200
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Locations

Country	Name	City	State
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 15 minutes	No