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

NCT01264575 | Completed

• 1 other identifier: SMC-2010-12-18
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Total Knee Replacement Arthroplasty

Keywords

spinal anesthesia; intrathecal bupivacaine; epinephrine; ED50; ED95

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects of the various intrathecal bupivacaine dose

  during surgery (average two hours)

Study Arms (12)

BPV6E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

BPV7E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

BPV8E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

BPV9E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

BPV10E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

BPV11E1

EXPERIMENTAL

Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg

BPV6E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

BPV7E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

BPV8E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

BPV9E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

BPV10E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

BPV11E2

EXPERIMENTAL

Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Interventions

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine DRUG

intrathecal bupivacaine 6 mg with 100 mcg of epinephrine

Also known as: marcaine, epinephrine

BPV6E1

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine DRUG

intrathecal bupivacaine 7 mg with 100 mcg of epinephrine

Also known as: marcaine, epinephrine

BPV7E1

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine DRUG

intrathecal bupivacaine 8 mg with 100 mcg of epinephrine

Also known as: marcaine, epinephrine

BPV8E1

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine DRUG

intrathecal bupivacaine 9 mg with 100 mcg of epinephrine

Also known as: marcaine, epinephrine

BPV9E1

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine DRUG

intrathecal bupivacaine 10 mg with 100 mcg of epinephrine

Also known as: marcaine, epinephrine

BPV10E1

intrathecal bupivacaine 11 mg with epinephrine 100 mcg DRUG

intrathecal bupivacaine 11 mg with epinephrine 100 mcg

Also known as: marcaine, epinephrine

BPV11E1

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 6 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV6E2

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 7 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV7E2

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV8E2

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 9 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV9E2

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 10 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV10E2

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine DRUG

intrathecal bupivacaine 11 mg with 200 mcg of epinephrine

Also known as: bupivacaine, epinephrine

BPV11E2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul Medical Center: lead

Study Sites (1)

Seoul Medical Center

Seoul, 135-740, South Korea

Location

MeSH Terms

Interventions

Epinephrine; Bupivacaine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds

Study Officials

• Won Ho Kim, M.D.

  Seoul Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

KR (1)