Labor PainPhase 2NCT04541719
Patient Controlled Remifentanil Analgesia for Normal Labour
A Phase 2 study testing Epidural analgesia in people with Labor Pain and Full Term Pregnancy, run by Mansoura University at 1 site in Egypt.
Trial summary
Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain, Full Term Pregnancy
- What is being tested?
- Epidural analgesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Jul 2018
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age > 36 weeks
- American Society of Anesthesiologists physical class I to III
Who cannot join
- Allergy to study solution
- Contraindications to epidural analgesia
- Non consented parturients
- Communications barriers.
- Intrauterine foetal growth retardation
- Foetal distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.
Read the detailed description
We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on:
- Peripartum analgesia
- Overall patient's satisfaction
- Maternal adverse effects
- Neonatal outcomes
- Conditions
- Labor Pain, Full Term Pregnancy
- Being tested
- Patient-controlled remifentanil analgesia, Epidural analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled remifentanil analgesiaDrug
Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min
Epidural analgesiaDrug
Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr
| Study group | Role | What they receive |
|---|---|---|
| Patient-controlled remifentanil analgesia | Active comparator | Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery Receives: Drug: Patient-controlled remifentanil analgesia |
| Epidural analgesia | Placebo comparator | Patients will received continuous epidural analgesia starting from labour pain until delivery Receives: Drug: Epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient's satisfaction
As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)
Measured: For 24 hours after labour
Secondary outcomes (9)
Pain Visual Analog Score at rest
As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
Measured: For 24 hours after the start of labour pain
Pain Visual Analog Score on movement
As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
Measured: For 24 hours after the start of labour pain
Maternal nausea and vomiting
(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)
Measured: For 24 hours after the start of labour pain
Maternal respiratory depression
If respiratory rate decreases less than 10/min
Measured: For 24 hours after the start of labour pain
Neonatal Apgar score at 1 min
Assessed using 5-points Apgar score
Measured: For 5 min after birth
Neonatal Apgar score at 5 min
Assessed using 5-points Apgar score
Measured: For 5 min after birth
Neonatal blood PaO2
PaO2 value
Measured: For 5 min after birth
Neonatal blood PaCO2
PaCO2 value
Measured: For 5 min after birth
Neonatal blood pH
pH value
Measured: For 5 min after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Apr 2017
- Primary completion1 May 2018
- Study completion1 Jul 2018
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Alexandria University
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
- Investigators
- Nabil A Abd El Raouf, MD, Study chair, Professor in Cardiothoracic Ananesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541719
- Sponsor's protocol ID
- MFM-XYZ-2017
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT04541719
- Acronym / sponsor ID
- MFM-XYZ-2017
- Conditions
- Labor Pain, Full Term Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Alexandria University
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 9 Sep 2020 (actual)
- 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.
Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.
Detailed description
We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on:
- Peripartum analgesia
- Overall patient's satisfaction
- Maternal adverse effects
- Neonatal outcomes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled remifentanil analgesia | Active comparator | Drug: Patient-controlled remifentanil analgesiaPatients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery |
| Epidural analgesia | Placebo comparator | Drug: Epidural analgesiaPatients will received continuous epidural analgesia starting from labour pain until delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational age > 36 weeks
- American Society of Anesthesiologists physical class I to III
Key exclusion criteria (6 listed)
- Allergy to study solution
- Contraindications to epidural analgesia
- Non consented parturients
- Communications barriers.
- Intrauterine foetal growth retardation
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 |
|---|---|---|
| Patient-controlled remifentanil analgesiaPatient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min | Drug | Patient-controlled remifentanil analgesia |
| Epidural analgesiaPatients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr | Drug | Epidural analgesia |
Primary outcome
Overall patient's satisfaction
Time frame: For 24 hours after labour
As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)
9 secondary outcomes
Pain Visual Analog Score at rest
Time frame: For 24 hours after the start of labour pain
Pain Visual Analog Score on movement
Time frame: For 24 hours after the start of labour pain
Maternal nausea and vomiting
Time frame: For 24 hours after the start of labour pain
Maternal respiratory depression
Time frame: For 24 hours after the start of labour pain
Neonatal Apgar score at 1 min
Time frame: For 5 min after birth
Neonatal Apgar score at 5 min
Time frame: For 5 min after birth
Neonatal blood PaO2
Time frame: For 5 min after birth
Neonatal blood PaCO2
Time frame: For 5 min after birth
Neonatal blood pH
Time frame: For 5 min after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nabil A Abd El Raouf, MD study chair
Professor in Cardiothoracic Ananesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epidural analgesia in people with Labor Pain and Full Term Pregnancy, run by Mansoura University at 1 site in Egypt.
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 6 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: withdrawn, as of the sponsor's last update on 9 Sep 2020. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Overall patient's satisfaction (time frame: For 24 hours after labour). 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 9 Sep 2020.