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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01264575

Enrollment

162

Registered

2010-12-22

Start date

2009-12-31

Completion date

2011-01-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Total Knee Replacement Arthroplasty

Keywords

spinal anesthesia, intrathecal bupivacaine, epinephrine, ED50, ED95

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.

Interventions

DRUGintrathecal bupivacaine 6 mg with 100 mcg of epinephrine

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

DRUGintrathecal bupivacaine 7 mg with 100 mcg of epinephrine

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

DRUGintrathecal bupivacaine 8 mg with 100 mcg of epinephrine

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

DRUGintrathecal bupivacaine 9 mg with 100 mcg of epinephrine

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

DRUGintrathecal bupivacaine 10 mg with 100 mcg of epinephrine

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

DRUGintrathecal bupivacaine 11 mg with epinephrine 100 mcg

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

DRUGintrathecal bupivacaine 6 mg with 200 mcg of epinephrine

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

DRUGintrathecal bupivacaine 7 mg with 200 mcg of epinephrine

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

DRUGintrathecal bupivacaine 8 mg with 200 mcg of epinephrine

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

DRUGintrathecal bupivacaine 9 mg with 200 mcg of epinephrine

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

DRUGintrathecal bupivacaine 10 mg with 200 mcg of epinephrine

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

DRUGintrathecal bupivacaine 11 mg with 200 mcg of epinephrine

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026