Anesthesia, ConductionNCT00636974
A Randomised Comparison on the Dose Requirement Between, Levobupivacaine, Ropivacaine and Bupivacaine in Intrathecal Anaesthesia
A study testing Combined spinal epidural anaesthesia in people with Anesthesia, Conduction and Surgery, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Conduction, Surgery
- What is being tested?
- Combined spinal epidural anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Jul 2008
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- body weight=40-90kg,
- height higher than 145cm
Who cannot join
- Known hypersensitivity to amide local anaesthetics,
- patients who do not understand English and Chinese,
- Body mass index higher than 35 kg per sq metre
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimum Local Anaesthetic Dose for Intrathecal Anaesthesia: a Randomised Comparison Between Levobupivacaine, Ropivacaine and Bupivacaine
To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery
- Conditions
- Anesthesia, Conduction, Surgery
- Being tested
- Combined spinal epidural anaesthesia
- Keywords
- Patients who are going to have regional anaesthesia for lower limbs surgery., Leg Surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined spinal epidural anaesthesiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug
Measured: 50 minutes after the intrathecal injection of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJan 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- 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
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Ying Yin Lee, Dr, Principal investigator, Department of Anaesthesiology, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636974
- Sponsor's protocol ID
- KW/FR/05-025
- Other IDs
- HARECCTR0500056
- Status last verified
- Oct 2013
- First submitted
- 19 Dec 2007
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Local Anaesthetic Dose for Intrathecal Anaesthesia: a Randomised Comparison Between Levobupivacaine, Ropivacaine and Bupivacaine
- ClinicalTrials.gov ID
- NCT00636974
- Acronym / sponsor ID
- KW/FR/05-025
- Conditions
- Anesthesia, Conduction, Surgery
- Keywords
- Patients who are going to have regional anaesthesia for lower limbs surgery., Leg Surgery.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jan 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Mar 2008 (estimated)
- 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.
To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- body weight=40-90kg,
- height higher than 145cm
Key exclusion criteria (3 listed)
- Known hypersensitivity to amide local anaesthetics,
- patients who do not understand English and Chinese,
- Body mass index higher than 35 kg per sq metre
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 |
|---|---|---|
| Combined spinal epidural anaesthesia | Procedure or surgery | – |
Primary outcome
Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug
Time frame: 50 minutes after the intrathecal injection of the study drug
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 23 Oct 2013.
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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.
Ying Yin Lee, Dr principal investigator
Department of Anaesthesiology, Kwong Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined spinal epidural anaesthesia in people with Anesthesia, Conduction and Surgery, run by Hospital Authority, Hong Kong 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 3 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 23 Oct 2013. 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?
Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug (time frame: 50 minutes after the intrathecal injection of the study drug). 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 23 Oct 2013.