Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine

Withdrawn

• Conditions: Mononeuropathy of the Median Nerve, Mild

• Registration Number: NCT02141841
• Lead Sponsor: China Three Gorges University, Yichang, China

Brief Summary

This study was performed in 131 adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia. Patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain bupivacaine, determined by Dixon's method. The degree of motor block after intrathecal administration of each concentration was evaluated by the modified Bromage and Hip motor function score. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ASA physical status I-II adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal component of established combined epidural-spinal anesthesia, with the epidural component to be used if there was a need for intra-operative analgesic supplementation or for postoperative analgesia.

Exclusion Criteria

• Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant were excluded from this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the median effect concentration of bupivacaine	The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration	The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration
sensory block level	20 minutes	the sensory level was assessed by the pinprick or ice at interval 5 minutes and 2 0minutes after injection of spinal bupivacaine.

Trial Locations

Locations (1)

China Three Gorges University; 🇨🇳 Yichang, Hubei, China