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

Seoul Medical Center

Status: Completed

Conditions: Spinal Anesthesia; Total Knee Replacement Arthroplasty

Treatments: Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg; Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine; Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01264575

SMC-2010-12-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

162 participants in 12 patient groups

BPV6E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

BPV7E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

BPV8E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

BPV9E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

BPV10E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

BPV11E1

Experimental group

Treatment:

Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg

BPV6E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

BPV7E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

BPV8E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

BPV9E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

BPV10E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

BPV11E2

Experimental group

Treatment:

Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine