Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine

August 2, 2011 updated by: Seoul Medical Center

The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty

The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patients undergoing elective total knee replacement arthroplasty

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.
  • The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPV6NO
Drug: BPV6NO
intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV7NO
Drug: BPV7NO
intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV8NO
Drug: BPV8NO
intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV9NO
Drug: BPV9NO
intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV10NO
Drug: BPV10NO
intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV11NO
Drug: BPV11NO
intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV6O
Drug: BPV6O
intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV7O
Drug: BPV7O
intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV8O
Drug: BPV8O
intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV9O
Drug: BPV9O
intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV10O
Drug: BPV10O
intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV11O
Drug: BPV11O
intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of spinal anesthesia
Time Frame: every ten minutes during the surgery
a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery
every ten minutes during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first request for supplemental analgesia
Time Frame: every ten minutes during and after surgery
for failure cases: it is the time of failure for success cases : it is the time of first postoperative pain
every ten minutes during and after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2010-1-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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