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

Not Applicable

Completed

• Conditions: Arthroplasty, Knee
• Interventions: Drug: BPV7NO; Drug: BPV8NO; Drug: BPV9NO; Drug: BPV6NO; Drug: BPV10NO; Drug: BPV11NO; Drug: BPV6O; Drug: BPV7O; Drug: BPV8O; Drug: BPV9O; Drug: BPV10O; Drug: BPV11O

• Registration Number: NCT01291186
• Lead Sponsor: Seoul Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPV7NO	BPV7NO	-
BPV8NO	BPV8NO	-
BPV9NO	BPV9NO	-
BPV6NO	BPV6NO	-
BPV10NO	BPV10NO	-
BPV11NO	BPV11NO	-
BPV6O	BPV6O	-
BPV7O	BPV7O	-
BPV8O	BPV8O	-
BPV9O	BPV9O	-
BPV10O	BPV10O	-
BPV11O	BPV11O	-

Primary Outcome Measures

Name	Time	Method
success of spinal anesthesia	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 Outcome Measures

Name	Time	Method
time to first request for supplemental analgesia	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

Trial Locations

Locations (1)

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of