StressPhase 1NO PAINNCT01013558
New Options for Preoperative Anesthesia in Intrauterine Needling
A Phase 1 study testing Remifentanil and saline in people with Stress and Pain, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Remifentanil and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2004to Dec 2007
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton pregnancy
- clinically indicated intrauterine transfusion
- red cell alloimmunisation
Who cannot join
- severe adipositas
- suspicion of structural anomalies
- fetal hydrops
- contraindication for remifentanil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling
The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.
- Being tested
- Remifentanil, saline
- Keywords
- fetal pain, intrauterine, needling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
0.15 microgram/kg/min continuous infusion.
salineDrug
continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Active comparator | Not described Receives: Drug: Remifentanil |
| saline | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
Measured: 15-60 minutes
Secondary outcomes (1)
influence of analgesics (remifentanil) on the fetal stress response
Measured: 15-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionDec 2007
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 StressStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leuven University Medical Center
- Investigators
- Frank P.H.A. Vandenbussche, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013558
- Sponsor's protocol ID
- P04.014
- Acronym
- NO PAIN
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Andrewartha K, Grivell RM. Perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures. Cochrane Database Syst Rev. 2022 May 13;5(5):CD011068. doi: 10.1002/14651858.CD011068.pub2.
PubMed 35553414
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling
- ClinicalTrials.gov ID
- NCT01013558
- Acronym / sponsor ID
- NO PAIN / P04.014
- Keywords
- fetal pain, intrauterine, needling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Leuven University Medical Center
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Nov 2009 (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.
The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Active comparator | Drug: Remifentanil |
| saline | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- singleton pregnancy
- clinically indicated intrauterine transfusion
- red cell alloimmunisation
Key exclusion criteria (4 listed)
- severe adipositas
- suspicion of structural anomalies
- fetal hydrops
- contraindication for remifentanil
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 |
|---|---|---|
| Remifentanil0.15 microgram/kg/min continuous infusion. | Drug | remifentanil |
| salinecontinuous infusion | Drug | saline |
Primary outcome
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
Time frame: 15-60 minutes
1 secondary outcome
influence of analgesics (remifentanil) on the fetal stress response
Time frame: 15-60 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 8 Dec 2009.
- Derived from this study: PubMed 35553414Andrewartha K, Grivell RM. Perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures. Cochrane Database Syst Rev. 2022 May 13;5(5):CD011068. doi: 10.1002/14651858.CD011068.pub2.
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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.
Frank P.H.A. Vandenbussche, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remifentanil and saline in people with Stress and Pain, run by Leiden University Medical Center at 1 site in Netherlands.
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 3 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 8 Dec 2009. 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol (time frame: 15-60 minutes). 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 NCT01013558, 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 8 Dec 2009.