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

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Total Knee Replacement Arthroplasty
• Interventions: Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg; Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

• Registration Number: NCT01264575
• Lead Sponsor: Seoul Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-29
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPV7E1	intrathecal bupivacaine 7 mg with 100 mcg of epinephrine	-
BPV6E1	intrathecal bupivacaine 6 mg with 100 mcg of epinephrine	-
BPV8E1	intrathecal bupivacaine 8 mg with 100 mcg of epinephrine	-
BPV9E1	intrathecal bupivacaine 9 mg with 100 mcg of epinephrine	-
BPV10E1	intrathecal bupivacaine 10 mg with 100 mcg of epinephrine	-
BPV11E1	intrathecal bupivacaine 11 mg with epinephrine 100 mcg	-
BPV6E2	intrathecal bupivacaine 6 mg with 200 mcg of epinephrine	-
BPV7E2	intrathecal bupivacaine 7 mg with 200 mcg of epinephrine	-
BPV8E2	intrathecal bupivacaine 8 mg with 200 mcg of epinephrine	-
BPV9E2	intrathecal bupivacaine 9 mg with 200 mcg of epinephrine	-
BPV10E2	intrathecal bupivacaine 10 mg with 200 mcg of epinephrine	-
BPV11E2	intrathecal bupivacaine 11 mg with 200 mcg of epinephrine	-

Primary Outcome Measures

Name	Time	Method
the success of anesthesia	during the surgery (average two hours)	The individual dose would be considered to be successful if no epidural supplement is required during surgery.

Secondary Outcome Measures

Name	Time	Method
Adverse effects of the various intrathecal bupivacaine dose	during surgery (average two hours)	lowest systolic blood pressure, vasopressure requirements, nausea, vomitting

Trial Locations

Locations (1)

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of