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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Total Knee Replacement Arthroplasty
• Intervention / Treatment: Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine; Drug: intrathecal bupivacaine 7 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

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-740
    • Seoul Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPV6E1	Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine; intrathecal bupivacaine 6 mg with 100 mcg of epinephrine; Other Names: marcaine; epinephrine
Experimental: BPV7E1	Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine; intrathecal bupivacaine 7 mg with 100 mcg of epinephrine; Other Names: marcaine; epinephrine
Experimental: BPV8E1	Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine; intrathecal bupivacaine 8 mg with 100 mcg of epinephrine; Other Names: marcaine; epinephrine
Experimental: BPV9E1	Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine; intrathecal bupivacaine 9 mg with 100 mcg of epinephrine; Other Names: marcaine; epinephrine
Experimental: BPV10E1	Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine; intrathecal bupivacaine 10 mg with 100 mcg of epinephrine; Other Names: marcaine; epinephrine
Experimental: BPV11E1	Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg; intrathecal bupivacaine 11 mg with epinephrine 100 mcg; Other Names: marcaine; epinephrine
Experimental: BPV6E2	Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine; intrathecal bupivacaine 6 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine
Experimental: BPV7E2	Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine; intrathecal bupivacaine 7 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine
Experimental: BPV8E2	Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine; intrathecal bupivacaine 8 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine
Experimental: BPV9E2	Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine; intrathecal bupivacaine 9 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine
Experimental: BPV10E2	Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine; intrathecal bupivacaine 10 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine
Experimental: BPV11E2	Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine; intrathecal bupivacaine 11 mg with 200 mcg of epinephrine; Other Names: bupivacaine; epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 29, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: spinal anesthesia; epinephrine; ED50; ED95; intrathecal bupivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: SMC-2010-12-18