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NCT Number: NCT03899038

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

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia

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.

Primary outcomes

  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.

Secondary outcomes

  1. the upper level of the sensory block 25 min after bupivacaine injection

    Time frame: 25 min

    the upper level of the sensory block 25 min after bupivacaine injection

  2. the incidence of hypotension

    Time frame: during anethesia and operation

    the incidence of hypotension

  3. the duration of sensory spinal anaesthesia for the lower extremity

    Time frame: up to 3 days postoperation

    the duration of sensory spinal anaesthesia for the lower extremity

  4. postoperative neurological complications

    Time frame: up to 3 months postoperation

    postoperative neurological complications

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Acronym: MEDBST

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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