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

Arthroplasty, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291186
• Other study ID #: SMC-2010-1-14
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: August 2, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Seoul Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Arthroplasty, Knee

Intervention

Drug:
• BPV6NO
intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
• BPV7NO
intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
• BPV8NO
intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
• BPV9NO
intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
• BPV10NO
intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
• BPV11NO
intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
• BPV6O
intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
• BPV7O
intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
• BPV8O
intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
• BPV9O
intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
• BPV10O
intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
• BPV11O
intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2

Locations

Country	Name	City	State
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	every ten minutes during the surgery	No
Secondary	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	every ten minutes during and after surgery	No