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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013558
First Posted: November 13, 2009
Last Update Posted: December 8, 2009
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.
Collaborator:
Leuven University Medical Center
Information provided by:
Leiden University Medical Center
  Purpose
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 Intervention Phase
Stress Pain Drug: Remifentanil Drug: saline Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

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

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

Enrollment: 50
Study Start Date: September 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: remifentanil Drug: Remifentanil
0.15 microgram/kg/min continuous infusion.
Placebo Comparator: saline Drug: saline
continuous infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe adipositas
  • suspicion of structural anomalies
  • fetal hydrops
  • contraindication for remifentanil
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01013558


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

Responsible Party: F.P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01013558     History of Changes
Other Study ID Numbers: P04.014
First Submitted: November 10, 2009
First Posted: November 13, 2009
Last Update Posted: December 8, 2009
Last Verified: November 2009

Keywords provided by Leiden University Medical Center:
fetal pain
intrauterine
needling

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