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

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ClinicalTrials.gov Identifier: NCT03899038
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lower Limb Surgery Procedure: spinal anesthesia Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Deceasing
Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.
Procedure: 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.

Active Comparator: Similar
Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.
Procedure: 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.




Primary Outcome Measures :
  1. The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach [ Time Frame: up to 6 months ]
    The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach is based on 45 successful spinal anesthesia performed in patients undergoing lower limb surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899038


Contacts
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Contact: Wei Mei, MD 0086-13006162508 wmei@hust.edu.cn
Contact: Yong Liu, MD 0086-15007124668 hosp1yong@163.com

Locations
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China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Yong Liu, MD    0086-15007124668    hosp1yong@163.com   
Sub-Investigator: Wei Mei, MD.         
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Director: Mujun Chang, MD Tongji Hospital,Wuhan

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Responsible Party: Wei Mei, Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03899038     History of Changes
Other Study ID Numbers: US-Spinal
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents