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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03899038
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 15

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 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: Apr 8, 2019
• Actual Primary Completion Date: Jul 9, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach [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 Outcome Measures

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

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

2. the incidence of hypotension [during anethesia and operation]

   the incidence of hypotension

3. the duration of sensory spinal anaesthesia for the lower extremity [up to 3 days postoperation]

   the duration of sensory spinal anaesthesia for the lower extremity

4. postoperative neurological complications [up to 3 months postoperation]

   postoperative neurological complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Huazhong University of Science and Technology

Investigators

• Study Director: Mujun Chang, MD, Tongji Hospital,Wuhan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: US-Spinal
• First Posted: Apr 2, 2019
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Sep 18, 2019