New Options for Preoperative Anesthesia in Intrauterine Needling

Pain Clinical Trial

— NO PAIN  

Official title:

NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013558
• Other study ID #: P04.014
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: December 7, 2009
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: November 2009
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Stress

Intervention

Drug:
• Remifentanil
0.15 microgram/kg/min continuous infusion.
• saline
continuous infusion

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Leuven University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol		15-60 minutes	No
Secondary	influence of analgesics (remifentanil) on the fetal stress response		15-60 minutes	No