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

NCT03899038 | Completed

• 1 other identifier: US-Spinal
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  25 min

• the incidence of hypotension

  during anethesia and operation

• the duration of sensory spinal anaesthesia for the lower extremity

  up to 3 days postoperation

• postoperative neurological complications

  up to 3 months postoperation

Study Arms (2)

Deceasing

EXPERIMENTAL

Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.

Procedure: spinal anesthesia

Similar

ACTIVE COMPARATOR

Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.

Procedure: spinal anesthesia

Interventions

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.

Deceasing; Similar

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical statusⅠ- Ⅲ
• Lower limb surgery, expected operation time within 2 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mujun Chang, MD

  Tongji Hospital,Wuhan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 2, 2019
• Study Start: April 8, 2019
• Primary Completion: July 9, 2019
• Study Completion: July 31, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)