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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deceasing | Experimental | Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. |
|
| Similar | Active Comparator | Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach | 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| the upper level of the sensory block 25 min after bupivacaine injection | the upper level of the sensory block 25 min after bupivacaine injection | 25 min |
| the incidence of hypotension | the incidence of hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mujun Chang, MD | Tongji Hospital,Wuhan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| during anethesia and operation |
| the duration of sensory spinal anaesthesia for the lower extremity | the duration of sensory spinal anaesthesia for the lower extremity | up to 3 days postoperation |
| postoperative neurological complications | postoperative neurological complications | up to 3 months postoperation |