Acute PainNCT00450099
Minimum Local Anesthetic Volume of Bupivacaine in Labour Epidurals
A study testing bupivacaine in people with Acute Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Aug 2007
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I or II
- Full term (more than 37 weeks gestation)
- Singleton pregnancy, vertex presentation
- Regular painful contractions occurring at least every 5 minutes
- Cervical dilatation < 5 cm
Who cannot join
- Any contraindication to epidural anesthesia
- Accidental dural puncture
- Allergy or hypersensitivity to bupivacaine
- Women who have received opioids or sedative medications within the last 4 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Minimum Local Anesthetic Volume of 0.125% Bupivacaine in Labour Epidurals
Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Our hypothesis is that for each concentration of a certain drug, there has to be a minimum effective volume that will be associated with the best possible performance of the drug. This study is being conducted to find the minimum volume of bupivacaine (a local anesthetic) that produces successful analgesia in 95% of patients in labor.
Read the detailed description
Epidural administration of local anesthetics during labor produces analgesia, sympathetic block and motor block. The characteristics of the block depend on the volume and concentration of the local anesthetic that is used as well as the potential use of adjuncts. Although many researchers have investigated the efficacy of different drugs at different concentrations, the volumes used have been arbitrary. There is limited data regarding the minimum volume that is necessary for a successful anesthetic for a given concentration of bupivacaine.
This study is conducted as a prospective, randomized, up-down sequential allocation trial. The aim is to determine the minimum volume of 0.125% bupivacaine that will provide effective analgesia for 95% of parturients in the first stage of labor. The verbal numeric rating scale (VNRS) is used to rate the pain felt over the first 20 minutes, where 0 is no pain and 10 is the worst pain imaginable. After 20 minutes, if the VNRS was greater than 2, the volume of bupivacaine was considered inadequate and additional medication was given.
The volume of bupivacaine for the first patient was arbitrarily chosen as 8 ml, and the dose for each subsequent patient depends on the outcome of the previous injection. Doses will be increased or decreased in increments of 1 ml. If the previous response was ineffective, the next patient will receive 1 ml more than the last patient. If the response of the previous patient is effective, the Narayana rule, which is used to cluster doses around EV95, will be applied to determine if the dose remains the same or decreases.
50 patients will be included in the study. An estimate of EV95 will be calculated based on a logistic model with non-log-transformed doses, fit using Firth's penalized maximum likelihood approach for small sample bias correction. Confidence intervals will be calculated based on the profile likelihood approach.
- Conditions
- Acute Pain
- Being tested
- bupivacaine
- Keywords
- Epidural, Labor Analgesia, Bupivacaine, Dose-response, Minimum effective volume
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Epidural, bupivacaine Receives: Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Numeric Rating Scale (VNRS) less than or equal to 2 out of 10 during contraction
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startOct 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450099
- Sponsor's protocol ID
- 07-03
- Other IDs
- 05-0209-E
- Status last verified
- Dec 2007
- First submitted
- 19 Mar 2007
- Last updated
- 17 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimum Local Anesthetic Volume of 0.125% Bupivacaine in Labour Epidurals
- ClinicalTrials.gov ID
- NCT00450099
- Acronym / sponsor ID
- 07-03
- Conditions
- Acute Pain
- Keywords
- Epidural, Labor Analgesia, Bupivacaine, Dose-response, Minimum effective volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Mar 2007 (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.
Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Our hypothesis is that for each concentration of a certain drug, there has to be a minimum effective volume that will be associated with the best possible performance of the drug. This study is being conducted to find the minimum volume of bupivacaine (a local anesthetic) that produces successful analgesia in 95% of patients in labor.
Detailed description
Epidural administration of local anesthetics during labor produces analgesia, sympathetic block and motor block. The characteristics of the block depend on the volume and concentration of the local anesthetic that is used as well as the potential use of adjuncts. Although many researchers have investigated the efficacy of different drugs at different concentrations, the volumes used have been arbitrary. There is limited data regarding the minimum volume that is necessary for a successful anesthetic for a given concentration of bupivacaine.
This study is conducted as a prospective, randomized, up-down sequential allocation trial. The aim is to determine the minimum volume of 0.125% bupivacaine that will provide effective analgesia for 95% of parturients in the first stage of labor. The verbal numeric rating scale (VNRS) is used to rate the pain felt over the first 20 minutes, where 0 is no pain and 10 is the worst pain imaginable. After 20 minutes, if the VNRS was greater than 2, the volume of bupivacaine was considered inadequate and additional medication was given.
The volume of bupivacaine for the first patient was arbitrarily chosen as 8 ml, and the dose for each subsequent patient depends on the outcome of the previous injection. Doses will be increased or decreased in increments of 1 ml. If the previous response was ineffective, the next patient will receive 1 ml more than the last patient. If the response of the previous patient is effective, the Narayana rule, which is used to cluster doses around EV95, will be applied to determine if the dose remains the same or decreases.
50 patients will be included in the study. An estimate of EV95 will be calculated based on a logistic model with non-log-transformed doses, fit using Firth's penalized maximum likelihood approach for small sample bias correction. Confidence intervals will be calculated based on the profile likelihood approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bupivacaineEpidural, bupivacaine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA I or II
- Full term (more than 37 weeks gestation)
- Singleton pregnancy, vertex presentation
- Regular painful contractions occurring at least every 5 minutes
- Cervical dilatation < 5 cm
Key exclusion criteria (4 listed)
- Any contraindication to epidural anesthesia
- Accidental dural puncture
- Allergy or hypersensitivity to bupivacaine
- Women who have received opioids or sedative medications within the last 4 hours
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 |
|---|---|---|
| bupivacaine0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL. | Drug | 1 |
Primary outcome
Verbal Numeric Rating Scale (VNRS) less than or equal to 2 out of 10 during contraction
Time frame: 20 minutes
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 17 Dec 2007.
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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.
Jose CA Carvalho, MD PhD principal investigator
MOUNT SINAI 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 bupivacaine in people with Acute Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 5 inclusion and 4 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 17 Dec 2007. 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 Canada. 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?
Verbal Numeric Rating Scale (VNRS) less than or equal to 2 out of 10 during contraction (time frame: 20 minutes). 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 17 Dec 2007.