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

Seoul Medical Center108 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

108

Conditions

Arthroplasty, Knee

Interventions

BPV6NODRUG

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

BPV7NODRUG

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

BPV8NODRUG

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

BPV9NO

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

success of spinal anesthesia

a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery

Time frame: every ten minutes during the surgery

Secondary Outcomes

time to first request for supplemental analgesia

for failure cases: it is the time of failure for success cases : it is the time of first postoperative pain

Time frame: every ten minutes during and after surgery

Data from ClinicalTrials.gov

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