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NCT Number: NCT01291186

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

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.

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Key information

Conditions

Arthroplasty, Knee

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Medical Center

Seoul, 135-740, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BPV6NO

Drug

intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV7NO

Drug

intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV8NO

Drug

intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV9NO

Drug

intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV10NO

Drug

intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV11NO

Drug

intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV6O

Drug

intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV7O

Drug

intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV8O

Drug

intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV9O

Drug

intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV10O

Drug

intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

BPV11O

Drug

intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2

Other names: bupivacaine, epinephrine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2011
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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