PainNCT00465231
Preventive Analgesia in Multiparas Undergoing Induction of Labour
A study testing bupivacaine, fentanyl and preservative free saline in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- bupivacaine, fentanyl and preservative free saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Jun 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multiparous patients who had previous vaginal delivery, undergoing induction of labour
- Singleton Pregnancy
Who cannot join
- Morbid Obesity
- Patients who have received cortisol, opioids or sedatives within the last 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour
Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.
Read the detailed description
Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour.
The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.
- Conditions
- Pain
- Being tested
- bupivacaine, fentanyl, preservative free saline
- Keywords
- Induction of labour, Bupivacaine consumption, Prevention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine, fentanylDrug
10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml
preservative free salineDrug
10mL saline solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Epidural Receives: Drug: bupivacaine, fentanyl |
| 2 | Placebo comparator | Epidural - saline solution Receives: Drug: preservative free saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores (VAS) remain 3 or less
Measured: throughout the first stage of labor
Secondary outcomes (4)
Bupivacaine consumption
Measured: during labour
Urinary creatinine to cortisol ratio
Measured: during labour
Neonatal outcome
Measured: at delivery
Obstetric outcome
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startJan 2007
- Study completionJun 2007
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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
- NCT00465231
- Sponsor's protocol ID
- 07-01
- Other IDs
- 06-0230-A
- Status last verified
- Dec 2007
- First submitted
- 23 Apr 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
- Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour
- ClinicalTrials.gov ID
- NCT00465231
- Acronym / sponsor ID
- 07-01
- Conditions
- Pain
- Keywords
- Induction of labour, Bupivacaine consumption, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 24 Apr 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.
Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.
Detailed description
Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour.
The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: bupivacaine, fentanylEpidural |
| 2 | Placebo comparator | Drug: preservative free salineEpidural - saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Multiparous patients who had previous vaginal delivery, undergoing induction of labour
- Singleton Pregnancy
Key exclusion criteria (2 listed)
- Morbid Obesity
- Patients who have received cortisol, opioids or sedatives within the last 24 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 |
|---|---|---|
| bupivacaine, fentanyl10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml | Drug | 1 |
| preservative free saline10mL saline solution | Drug | 2 |
Primary outcome
Pain scores (VAS) remain 3 or less
Time frame: throughout the first stage of labor
4 secondary outcomes
Bupivacaine consumption
Time frame: during labour
Urinary creatinine to cortisol ratio
Time frame: during labour
Neonatal outcome
Time frame: at delivery
Obstetric outcome
Time frame: at delivery
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, fentanyl and preservative free saline in people with 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 2 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 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. Some participants in this study may receive a placebo. 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?
Pain scores (VAS) remain 3 or less (time frame: throughout the first stage of labor). 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.