Patient-controlled remifentanil analgesia during oocyte retrieval for IVF/ICSI procedures.
Completed
- Conditions
- Women undergoing IVF/ICSI proceduresOocyte retrievalPain
- Registration Number
- NL-OMON26955
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
1. Female subjects who undergo elective IVF/ICSI;
2. Age 18-45 years;
Exclusion Criteria
1. Not willing to receive analgesia;
2. Allergy for remifentanil or pethidine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain levels and as measured by 0-10 numeric rating scale (NRS);<br /><br>2. SpO2, heart rate and blood pressure during oocyte retrieval;<br /><br>3. Pain levels in the first 4 days post-puncture. <br><br /><br /><br>A pain intensity score calculated from an average of 12 ratings across 4 days demonstrated adequate reliability and excellent validity as a measure of the average pain. Furthermore, pain scores in the post-puncture period will be monitored using the McGill pain questionnaire.
- Secondary Outcome Measures
Name Time Method 1. Difference in pain between patients with or without endometriosis;<br /><br>2. Difference in puncture pain between left- and right ovary;<br /><br>3. Pain predictors including the expected pain levels, anxiety and pre-procedure pain;<br /><br>4. Pain scores in the first 4 days post-puncture;<br /><br>5. Level of sedation according to the Ramsey sedation scale;<br /><br>6. Use of post-puncture pain medication;<br /><br>7. Pregnancy rate;<br /><br>8. Treatment costs;<br /><br>9. Patient satisfaction with the analgesic method.