Arthroplasty, KneeNCT01291186
Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine
A study testing BPV6NO, BPV7NO and BPV8NO in people with Arthroplasty, Knee, run by Seoul Medical Center at 1 site in South Korea.
Trial summary
The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arthroplasty, Knee
- What is being tested?
- BPV6NO, BPV7NO and BPV8NO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2010
- 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
- Patients undergoing elective total knee replacement arthroplasty
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.
- The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty
The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.
Read the detailed description
The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.
- Conditions
- Arthroplasty, Knee
- Being tested
- BPV6NO, BPV7NO, BPV8NO, BPV9NO, BPV10NO
- Keywords
- spinal anesthesia, intrathecal bupivacaine, median effective dose, height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPV6NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
BPV7NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
BPV8NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
BPV9NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
BPV10NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
BPV11NODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
BPV6ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
BPV7ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
BPV8ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
BPV9ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
BPV10ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
BPV11ODrug
Also called bupivacaine, epinephrine
intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
| Study group | Role | What they receive |
|---|---|---|
| BPV6NO | Experimental | Not described Receives: Drug: BPV6NO |
| BPV7NO | Experimental | Not described Receives: Drug: BPV7NO |
| BPV8NO | Experimental | Not described Receives: Drug: BPV8NO |
| BPV9NO | Experimental | Not described Receives: Drug: BPV9NO |
| BPV10NO | Experimental | Not described Receives: Drug: BPV10NO |
| BPV11NO | Experimental | Not described Receives: Drug: BPV11NO |
| BPV6O | Active comparator | Not described Receives: Drug: BPV6O |
| BPV7O | Active comparator | Not described Receives: Drug: BPV7O |
| BPV8O | Active comparator | Not described Receives: Drug: BPV8O |
| BPV9O | Active comparator | Not described Receives: Drug: BPV9O |
| BPV10O | Active comparator | Not described Receives: Drug: BPV10O |
| BPV11O | Active comparator | Not described Receives: Drug: BPV11O |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of spinal anesthesia
a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery
Measured: every ten minutes during the surgery
Secondary outcomes (1)
time to first request for supplemental analgesia
for failure cases: it is the time of failure for success cases : it is the time of first postoperative pain
Measured: every ten minutes during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, KneeStudies 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, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Won Ho Kim, M.D., Principal investigator, Seoul Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291186
- Sponsor's protocol ID
- SMC-2010-1-14
- Status last verified
- Jan 2011
- First submitted
- 7 Feb 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01291186
- Acronym / sponsor ID
- SMC-2010-1-14
- Conditions
- Arthroplasty, Knee
- Keywords
- spinal anesthesia, intrathecal bupivacaine, median effective dose, height
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Feb 2011 (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.
The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.
Detailed description
The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| BPV6NO | Experimental | Drug: BPV6NO |
| BPV7NO | Experimental | Drug: BPV7NO |
| BPV8NO | Experimental | Drug: BPV8NO |
| BPV9NO | Experimental | Drug: BPV9NO |
| BPV10NO | Experimental | Drug: BPV10NO |
| BPV11NO | Experimental | Drug: BPV11NO |
| BPV6O | Active comparator | Drug: BPV6O |
| BPV7O | Active comparator | Drug: BPV7O |
| BPV8O | Active comparator | Drug: BPV8O |
| BPV9O | Active comparator | Drug: BPV9O |
| BPV10O | Active comparator | Drug: BPV10O |
| BPV11O | Active comparator | Drug: BPV11O |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective total knee replacement arthroplasty
Key exclusion criteria (2 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.
- The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.
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 |
|---|---|---|
| BPV6NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2 | Drug | BPV6NO |
| BPV7NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2 | Drug | BPV7NO |
| BPV8NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2 | Drug | BPV8NO |
| BPV9NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2 | Drug | BPV9NO |
| BPV10NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2 | Drug | BPV10NO |
| BPV11NOAlso: bupivacaine, epinephrineintrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2 | Drug | BPV11NO |
| BPV6OAlso: bupivacaine, epinephrineintrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2 | Drug | BPV6O |
| BPV7OAlso: bupivacaine, epinephrineintrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2 | Drug | BPV7O |
| BPV8OAlso: bupivacaine, epinephrineintrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2 | Drug | BPV8O |
| BPV9OAlso: bupivacaine, epinephrineintrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2 | Drug | BPV9O |
| BPV10OAlso: bupivacaine, epinephrineintrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2 | Drug | BPV10O |
| BPV11OAlso: bupivacaine, epinephrineintrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2 | Drug | BPV11O |
Primary outcome
success of spinal anesthesia
Time frame: every ten minutes during the surgery
a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery
1 secondary outcome
time to first request for supplemental analgesia
Time frame: every ten minutes during and after surgery
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 3 Aug 2011.
Related trials for Arthroplasty, Knee
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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 BPV6NO, BPV7NO and BPV8NO in people with Arthroplasty, Knee, 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 2 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 3 Aug 2011. 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?
success of spinal anesthesia (time frame: every ten minutes during the surgery). 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 3 Aug 2011.