PainPhase 3NCT00197327
Dilute Versus Concentrated Epidural Bupivacaine in Labor
A Phase 3 study testing Epidural bupivacaine (0.25% versus 0.0625%) in people with Pain and Labor Complications, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine. We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain, Labor Complications
- What is being tested?
- Epidural bupivacaine (0.25% versus 0.0625%)
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 1998to Mar 2000
- Phase
- Phase 3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation
Who cannot join
- narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.
This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine.
We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.
Read the detailed description
This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (PCEA).
- Conditions
- Pain, Labor Complications
- Being tested
- Epidural bupivacaine (0.25% versus 0.0625%)
- Keywords
- Labor Pain, Analgesia, Obstetrical, Pharmacology, Treatment Outcome
- Medical subject headings
- Pain, Obstetric Labor Complications, Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural bupivacaine (0.25% versus 0.0625%)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Anesthesia requirement:
a. total dose (mg) of bupivacaine administered
b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
c. total number of attempts for supplemental bupivacaine doses (including those denied)
Secondary outcomes (16)
1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
2. Speed of onset of analgesia.
3. Anesthesia variables (in labor q 1hr)
a. Pain score VAS during uterine contraction
b. sensory level
c. motor power
d. maternal blood pressure.
3.Obstetric outcome variables
a. 1st stage duration
b. 2nd stage duration
c. Expulsive efforts
d. Apgar scores at 1 and 5 min
e. Instrumental delivery
f. Cesarean section
g. Non-reassuring fetal heart rate tracing in labor
h. Occipito-posterior malrotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 1998
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Yehuda Ginosar, BSc MBBS, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197327
- Sponsor's protocol ID
- Primip-ginosar-HMO-CTIL
- Status last verified
- Mar 2003
- First submitted
- 13 Sep 2005
- Last updated
- 3 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.
- ClinicalTrials.gov ID
- NCT00197327
- Acronym / sponsor ID
- Primip-ginosar-HMO-CTIL
- Conditions
- Pain, Labor Complications
- Keywords
- Labor Pain, Analgesia, Obstetrical, Pharmacology, Treatment Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 1998
- Study completion
- Mar 2000
- First posted
- 20 Sep 2005 (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 study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine.
We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.
Detailed description
This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (PCEA).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation
Key exclusion criteria (1 listed)
- narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
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 |
|---|---|---|
| Epidural bupivacaine (0.25% versus 0.0625%) | Drug | – |
Primary outcome
1. Anesthesia requirement:
a. total dose (mg) of bupivacaine administered
b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
c. total number of attempts for supplemental bupivacaine doses (including those denied)
16 secondary outcomes
1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
2. Speed of onset of analgesia.
3. Anesthesia variables (in labor q 1hr)
a. Pain score VAS during uterine contraction
b. sensory level
c. motor power
d. maternal blood pressure.
3.Obstetric outcome variables
a. 1st stage duration
b. 2nd stage duration
c. Expulsive efforts
d. Apgar scores at 1 and 5 min
e. Instrumental delivery
f. Cesarean section
g. Non-reassuring fetal heart rate tracing in labor
h. Occipito-posterior malrotation
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 Mar 2006.
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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.
Yehuda Ginosar, BSc MBBS principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural bupivacaine (0.25% versus 0.0625%) in people with Pain and Labor Complications, run by Hadassah Medical Organization at 1 site in Israel.
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 3 Mar 2006. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
1. Anesthesia requirement:. The study lists 4 primary outcomes in all. 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 Mar 2006.