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

This study has been completed.
Sponsor:
Collaborator:
Leuven University Medical Center
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01013558
First received: November 10, 2009
Last updated: December 7, 2009
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • influence of analgesics (remifentanil) on the fetal stress response [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 10, 2009
Last Updated: December 7, 2009
Health Authority: Netherlands: Medical Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 23, 2014