LaborPhase 4NCT00801047
Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia
A Phase 4 study testing Bupivacaine epidural and Remifentanil in people with Labor and Pain, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia. Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- What is being tested?
- Bupivacaine epidural and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Jul 2012
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women
- American Society of Anesthesiologists physical status class I or II
- Body weight less than 110 kg
- In active labor (including induced labor and premature rupture of membranes)
- Cervical dilatation at 2-6 cm
- Regular contractions
Show all 9Show fewer
- Age between 18 and 40 years old
- Gestational age greater than 36 completed weeks
- Singleton pregnancy and vertex presentation
Who cannot join
- Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
- Narcotic administration in the previous 2 hours
- Previous uterine surgery
- Pre-eclampsia and the inability to adequately understand the consent form
- Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia
Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia.
Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).
- Being tested
- Bupivacaine epidural, Remifentanil
- Keywords
- Epidural, Labor, Remifentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine epiduralDrug
Bupivacaine 0.1%, fentanyl 1 mic/kg
RemifentanilDrug
40-50 mic per 1-2 min via PCA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Epidural group Receives: Drug: Bupivacaine epidural |
| 2 | Active comparator | Remifentanil iv PCA Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary analgesia end-point: VAS pain Score
Measured: 1-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaborStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Carolyn F Weiniger, MB ChB, Principal investigator, Hadassah HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801047
- Sponsor's protocol ID
- rem-epi-nov-2008- HMO-CTIL
- Status last verified
- Feb 2010
- First submitted
- 2 Dec 2008
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. No abstract available.
PubMed 18617388
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia
- ClinicalTrials.gov ID
- NCT00801047
- Acronym / sponsor ID
- rem-epi-nov-2008- HMO-CTIL
- Keywords
- Epidural, Labor, Remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Dec 2008 (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.
Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia.
Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bupivacaine epiduralEpidural group |
| 2 | Active comparator | Drug: RemifentanilRemifentanil iv PCA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy women
- American Society of Anesthesiologists physical status class I or II
- Body weight less than 110 kg
- In active labor (including induced labor and premature rupture of membranes)
- Cervical dilatation at 2-6 cm
Key exclusion criteria (5 listed)
- Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
- Narcotic administration in the previous 2 hours
- Previous uterine surgery
- Pre-eclampsia and the inability to adequately understand the consent form
- Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)
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 |
|---|---|---|
| Bupivacaine epiduralBupivacaine 0.1%, fentanyl 1 mic/kg | Drug | 1 |
| Remifentanil40-50 mic per 1-2 min via PCA | Drug | 2 |
Primary outcome
Primary analgesia end-point: VAS pain Score
Time frame: 1-6 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 21 Apr 2015.
- Background: PubMed 18617388Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. No abstract available.
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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.
Carolyn F Weiniger, MB ChB principal investigator
Hadassah HMO
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 epidural and Remifentanil in people with Labor and Pain, 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 9 inclusion and 5 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 21 Apr 2015. 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 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?
Primary analgesia end-point: VAS pain Score (time frame: 1-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801047, which also lists 1 linked publication.
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 21 Apr 2015.