Serum Bupivacaine LevelPhase 4NCT01636869
Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine in people with Serum Bupivacaine Level and Periarticular Block, run by Mahidol University at 1 site in Thailand.
Trial summary
Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Serum Bupivacaine Level, Periarticular Block, Total Knee Arthroplasty
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2012to Jul 2014
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 30-70 yr
- ASA I-II
- patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block
Who cannot join
- patient's refusal
- allergic to bupivacaine
- body weight less than 50 kg
- liver disease
- heart disease
- coagulopathy
- Hct<35%
- infection at both groin
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty
Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.
- Being tested
- Bupivacaine
- Keywords
- bupivacaine level, periarticular block, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation.
Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.
| Study group | Role | What they receive |
|---|---|---|
| bupicavaine | Experimental | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block
Measured: 2 hours
Secondary outcomes (1)
bupivacaine toxicity
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum Bupivacaine LevelStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saowaphak Lapmahapaisan, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636869
- Sponsor's protocol ID
- 010/2555
- Status last verified
- Jul 2014
- First submitted
- 5 Jul 2012
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01636869
- Acronym / sponsor ID
- 010/2555
- Keywords
- bupivacaine level, periarticular block, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jul 2012 (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.
Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bupicavaine | Experimental | Drug: Bupivacaine |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of 30-70 yr
- ASA I-II
- patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block
Key exclusion criteria (8 listed)
- patient's refusal
- allergic to bupivacaine
- body weight less than 50 kg
- liver disease
- heart disease
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 |
|---|---|---|
| Bupivacaine20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation. Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block. | Drug | bupicavaine |
Primary outcome
plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block
Time frame: 2 hours
1 secondary outcome
bupivacaine toxicity
Time frame: 24 hr
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 28 Jul 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine in people with Serum Bupivacaine Level and Periarticular Block, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 8 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 28 Jul 2014. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block (time frame: 2 hours). 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 28 Jul 2014.