Lower Limb SurgeryMEDBSTNCT03899038
Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
A study testing spinal anesthesia in people with Lower Limb Surgery, run by Huazhong University of Science and Technology at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Limb Surgery
- What is being tested?
- spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Lower limb surgery, expected operation time within 2 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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.
Read the 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.
- Conditions
- Lower Limb Surgery
- Being tested
- spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Deceasing | Experimental | Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. Receives: Procedure: spinal anesthesia |
| Similar | Active comparator | Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (4)
the upper level of the sensory block 25 min after bupivacaine injection
the upper level of the sensory block 25 min after bupivacaine injection
Measured: 25 min
the incidence of hypotension
the incidence of hypotension
Measured: during anethesia and operation
the duration of sensory spinal anaesthesia for the lower extremity
the duration of sensory spinal anaesthesia for the lower extremity
Measured: up to 3 days postoperation
postoperative neurological complications
postoperative neurological complications
Measured: up to 3 months postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start8 Apr 2019
- Primary completion9 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Mujun Chang, MD, Study director, Tongji Hospital,Wuhan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899038
- Sponsor's protocol ID
- US-Spinal
- Acronym
- MEDBST
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
- ClinicalTrials.gov ID
- NCT03899038
- Acronym / sponsor ID
- MEDBST / US-Spinal
- Conditions
- Lower Limb Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deceasing | Experimental | Procedure: spinal anesthesiaSpinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. |
| Similar | Active comparator | Procedure: spinal anesthesiaSpinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Lower limb surgery, expected operation time within 2 hours
Key exclusion criteria (7 listed)
- Patient refusal
- American Society of Anesthesiologists physical status IV/V
- Peripheral neuropathy
- skin infection at the site of injection
- allergy to bupivacaine or lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaPatients 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. | Procedure or surgery | Deceasing, Similar |
Primary outcome
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.
4 secondary outcomes
the upper level of the sensory block 25 min after bupivacaine injection
Time frame: 25 min
the incidence of hypotension
Time frame: during anethesia and operation
the duration of sensory spinal anaesthesia for the lower extremity
Time frame: up to 3 days postoperation
postoperative neurological complications
Time frame: up to 3 months postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Lower Limb Surgery
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujun Chang, MD study director
Tongji Hospital,Wuhan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia in people with Lower Limb Surgery, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.