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New Options for Preoperative Anesthesia in Intrauterine Needling

NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01013558
Acronym
NO PAIN
Enrollment
50
Registered
2009-11-13
Start date
2004-09-30
Completion date
2007-12-31
Last updated
2009-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Stress

Keywords

fetal pain, intrauterine, needling

Brief 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. 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.

Interventions

DRUGRemifentanil

0.15 microgram/kg/min continuous infusion.

DRUGsaline

continuous infusion

Sponsors

Leuven University Medical Center
CollaboratorUNKNOWN
Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* singleton pregnancy * clinically indicated intrauterine transfusion * red cell alloimmunisation

Exclusion criteria

* severe adipositas * suspicion of structural anomalies * fetal hydrops * contraindication for remifentanil

Design outcomes

Primary

MeasureTime frame
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol15-60 minutes

Secondary

MeasureTime frame
influence of analgesics (remifentanil) on the fetal stress response15-60 minutes

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026