New Options for Preoperative Anesthesia in Intrauterine Needling (NO PAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013558
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : December 8, 2009
Leuven University Medical Center
Information provided by:
Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Stress Pain Drug: Remifentanil Drug: saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling
Study Start Date : September 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: remifentanil Drug: Remifentanil
0.15 microgram/kg/min continuous infusion.

Placebo Comparator: saline Drug: saline
continuous infusion

Primary Outcome Measures :
  1. evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol [ Time Frame: 15-60 minutes ]

Secondary Outcome Measures :
  1. influence of analgesics (remifentanil) on the fetal stress response [ Time Frame: 15-60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013558

Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Leuven University Medical Center
Principal Investigator: Frank P.H.A. Vandenbussche, MD PhD Leiden University Medical Center

Responsible Party: F.P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center Identifier: NCT01013558     History of Changes
Other Study ID Numbers: P04.014
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: December 8, 2009
Last Verified: November 2009

Keywords provided by Leiden University Medical Center:
fetal pain

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General