Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2019-07-31

Brief Summary

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This study aims to determine the minimum effective dose of bupivacaine 0.5% in 90% of patients undergoing lower limb surgery with ultrasound-guided spinal anesthesia using Taylor's approach. A biased coin design up-and-down sequential method is applied. The initial dose is 15 mg of bupivacaine 0.5%. After 45 successful spinal anesthesia, the ED90 of bupivacaine 0.5% will be calculated.

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Detailed Description

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The minimum effective dose of local anesthetics for spinal anesthesia using Taylor's approach is not known. This study aims to determine the minimum effective dose of bupivacaine 0.5% using a biased coin design up-and-down sequential method. Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. The initial dose is chosen as 15 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the bupivacaine dose is increased by 2 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 2 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks will be accomplished. MED90 will be calculated by isotonic regression.

Conditions

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Lower Limb Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deceasing

Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. Various doses of bupivacaine 0.5% (Bupivacaine hydrochloride injection, Harvest Pharmaceutical CO., LTD., Shanghai, China) will be administered.

Similar

Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type PROCEDURE

Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. Various doses of bupivacaine 0.5% (Bupivacaine hydrochloride injection, Harvest Pharmaceutical CO., LTD., Shanghai, China) will be administered.

Interventions

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spinal anesthesia

Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. Various doses of bupivacaine 0.5% (Bupivacaine hydrochloride injection, Harvest Pharmaceutical CO., LTD., Shanghai, China) will be administered.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical statusⅠ- Ⅲ
* Lower limb surgery, expected operation time within 2 hours

Exclusion Criteria

* Patient refusal
* American Society of Anesthesiologists physical status IV/V
* Peripheral neuropathy
* skin infection at the site of injection
* allergy to bupivacaine or lidocaine
* BMI \> 35 kg/m2
* coagulation disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No