Spinal AnesthesiaNCT01264575
ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
A study testing intrathecal bupivacaine 6 mg with 100 mcg of epinephrine, intrathecal bupivacaine 7 mg with 100 mcg of epinephrine and intrathecal bupivacaine 8 mg with 100 mcg of epinephrine in people with Spinal Anesthesia and Total Knee Replacement Arthroplasty, run by Seoul Medical Center at 1 site in South Korea.
Trial summary
This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Spinal Anesthesia, Total Knee Replacement Arthroplasty
- What is being tested?
- intrathecal bupivacaine 6 mg with 100 mcg of epinephrine, intrathecal bupivacaine 7 mg with 100 mcg of epinephrine and intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Jan 2011
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with ASA class I or II scheduled for total knee replacement surgery
Who cannot join
- Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.
Read the detailed description
Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.
After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.
- Being tested
- intrathecal bupivacaine 6 mg with 100 mcg of epinephrine, intrathecal bupivacaine 7 mg with 100 mcg of epinephrine, intrathecal bupivacaine 8 mg with 100 mcg of epinephrine, intrathecal bupivacaine 9 mg with 100 mcg of epinephrine, intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
- Keywords
- spinal anesthesia, intrathecal bupivacaine, epinephrine, ED50, ED95
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal bupivacaine 6 mg with 100 mcg of epinephrineDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
intrathecal bupivacaine 7 mg with 100 mcg of epinephrineDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
intrathecal bupivacaine 8 mg with 100 mcg of epinephrineDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
intrathecal bupivacaine 9 mg with 100 mcg of epinephrineDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
intrathecal bupivacaine 10 mg with 100 mcg of epinephrineDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
intrathecal bupivacaine 11 mg with epinephrine 100 mcgDrug
Also called marcaine, epinephrine
intrathecal bupivacaine 11 mg with epinephrine 100 mcg
intrathecal bupivacaine 6 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
intrathecal bupivacaine 7 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
intrathecal bupivacaine 8 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
intrathecal bupivacaine 9 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
intrathecal bupivacaine 10 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
intrathecal bupivacaine 11 mg with 200 mcg of epinephrineDrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
| Study group | Role | What they receive |
|---|---|---|
| BPV6E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine |
| BPV7E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine |
| BPV8E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine |
| BPV9E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine |
| BPV10E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine |
| BPV11E1 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg |
| BPV6E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine |
| BPV7E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine |
| BPV8E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine |
| BPV9E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine |
| BPV10E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine |
| BPV11E2 | Experimental | Not described Receives: Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success of anesthesia
The individual dose would be considered to be successful if no epidural supplement is required during surgery.
Measured: during the surgery (average two hours)
Secondary outcomes (1)
Adverse effects of the various intrathecal bupivacaine dose
lowest systolic blood pressure, vasopressure requirements, nausea, vomitting
Measured: during surgery (average two hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, Seoul Medical Center
- Investigators
- Won Ho Kim, M.D., Principal investigator, Seoul Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264575
- Sponsor's protocol ID
- SMC-2010-12-18
- Status last verified
- Jan 2012
- First submitted
- 20 Dec 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01264575
- Acronym / sponsor ID
- SMC-2010-12-18
- Keywords
- spinal anesthesia, intrathecal bupivacaine, epinephrine, ED50, ED95
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Seoul Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Dec 2010 (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.
This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.
Detailed description
Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.
After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| BPV6E1 | Experimental | Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine |
| BPV7E1 | Experimental | Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine |
| BPV8E1 | Experimental | Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine |
| BPV9E1 | Experimental | Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine |
| BPV10E1 | Experimental | Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine |
| BPV11E1 | Experimental | Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg |
| BPV6E2 | Experimental | Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine |
| BPV7E2 | Experimental | Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine |
| BPV8E2 | Experimental | Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine |
| BPV9E2 | Experimental | Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine |
| BPV10E2 | Experimental | Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine |
| BPV11E2 | Experimental | Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with ASA class I or II scheduled for total knee replacement surgery
Key exclusion criteria (1 listed)
- Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
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 |
|---|---|---|
| intrathecal bupivacaine 6 mg with 100 mcg of epinephrineAlso: marcaine, epinephrineintrathecal bupivacaine 6 mg with 100 mcg of epinephrine | Drug | BPV6E1 |
| intrathecal bupivacaine 7 mg with 100 mcg of epinephrineAlso: marcaine, epinephrineintrathecal bupivacaine 7 mg with 100 mcg of epinephrine | Drug | BPV7E1 |
| intrathecal bupivacaine 8 mg with 100 mcg of epinephrineAlso: marcaine, epinephrineintrathecal bupivacaine 8 mg with 100 mcg of epinephrine | Drug | BPV8E1 |
| intrathecal bupivacaine 9 mg with 100 mcg of epinephrineAlso: marcaine, epinephrineintrathecal bupivacaine 9 mg with 100 mcg of epinephrine | Drug | BPV9E1 |
| intrathecal bupivacaine 10 mg with 100 mcg of epinephrineAlso: marcaine, epinephrineintrathecal bupivacaine 10 mg with 100 mcg of epinephrine | Drug | BPV10E1 |
| intrathecal bupivacaine 11 mg with epinephrine 100 mcgAlso: marcaine, epinephrineintrathecal bupivacaine 11 mg with epinephrine 100 mcg | Drug | BPV11E1 |
| intrathecal bupivacaine 6 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 6 mg with 200 mcg of epinephrine | Drug | BPV6E2 |
| intrathecal bupivacaine 7 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 7 mg with 200 mcg of epinephrine | Drug | BPV7E2 |
| intrathecal bupivacaine 8 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 8 mg with 200 mcg of epinephrine | Drug | BPV8E2 |
| intrathecal bupivacaine 9 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 9 mg with 200 mcg of epinephrine | Drug | BPV9E2 |
| intrathecal bupivacaine 10 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 10 mg with 200 mcg of epinephrine | Drug | BPV10E2 |
| intrathecal bupivacaine 11 mg with 200 mcg of epinephrineAlso: bupivacaine, epinephrineintrathecal bupivacaine 11 mg with 200 mcg of epinephrine | Drug | BPV11E2 |
Primary outcome
the success of anesthesia
Time frame: during the surgery (average two hours)
The individual dose would be considered to be successful if no epidural supplement is required during surgery.
1 secondary outcome
Adverse effects of the various intrathecal bupivacaine dose
Time frame: during surgery (average two hours)
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 31 Jan 2012.
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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.
Won Ho Kim, M.D. principal investigator
Seoul Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal bupivacaine 6 mg with 100 mcg of epinephrine, intrathecal bupivacaine 7 mg with 100 mcg of epinephrine and intrathecal bupivacaine 8 mg with 100 mcg of epinephrine in people with Spinal Anesthesia and Total Knee Replacement Arthroplasty, run by Seoul Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 31 Jan 2012. 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 South Korea. 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 success of anesthesia (time frame: during the surgery (average two 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 31 Jan 2012.