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

Lower Limb Surgery Clinical Trial

— MEDBST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899038
• Other study ID #: US-Spinal
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 31, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status?- ?

• 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

Related Conditions & MeSH terms

• Lower Limb Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	the incidence of hypotension	the incidence of hypotension	during anethesia and operation
Secondary	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
Secondary	postoperative neurological complications	postoperative neurological complications	up to 3 months postoperation