ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Spinal Anesthesia Clinical Trial

Official title:

ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264575
• Other study ID #: SMC-2010-12-18
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: January 29, 2012
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• Source: Seoul Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.

Description:

Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.

After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patients with ASA class I or II scheduled for total knee replacement surgery

Exclusion Criteria:

• Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.

Study Design

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

Related Conditions & MeSH terms

• Spinal Anesthesia
• Total Knee Replacement Arthroplasty

Intervention

Drug:
• intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
• intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
• intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
• intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
• intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
• intrathecal bupivacaine 11 mg with epinephrine 100 mcg
intrathecal bupivacaine 11 mg with epinephrine 100 mcg
• intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
• intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
• intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
• intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
• intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
• intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
intrathecal bupivacaine 11 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 success of anesthesia	The individual dose would be considered to be successful if no epidural supplement is required during surgery.	during the surgery (average two hours)	No
Secondary	Adverse effects of the various intrathecal bupivacaine dose	lowest systolic blood pressure, vasopressure requirements, nausea, vomitting	during surgery (average two hours)	Yes