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

December 7, 2009 updated by: Leiden University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline
Drug: saline
continuous infusion
Active Comparator: remifentanil
Drug: Remifentanil
0.15 microgram/kg/min continuous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
Time Frame: 15-60 minutes
15-60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
influence of analgesics (remifentanil) on the fetal stress response
Time Frame: 15-60 minutes
15-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Leuven University Medical Center

Investigators

  • Principal Investigator: Frank P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

December 8, 2009

Last Update Submitted That Met QC Criteria

December 7, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04.014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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