|- candidate number||8265|
|- NTR Number||NTR2431|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jul-2010|
|- Secondary IDs||ANES2010-05 METC VUmc|
|- Public Title||Patient-controlled remifentanil analgesia during oocyte retrieval for IVF/ICSI procedures.|
|- Scientific Title||Patient-controlled remifentanil analgesia during oocyte retrieval for IVF/ICSI procedures.|
|- ACRONYM||RELIEF study|
|- hypothesis||Is patient-controlled analgesia with remifentanil more efficacious and equally safe as pethidine as analgesic strategy during ultrasound guided transvaginal oocyte retrieval.|
|- Healt Condition(s) or Problem(s) studied||Pain, IVF, ICSI, Oocyte retrieval|
|- Inclusion criteria||1. Female subjects who undergo elective IVF/ICSI;|
2. Age 18-45 years;
3. Informed consent.
|- Exclusion criteria||1. Not willing to receive analgesia;|
2. Allergy for remifentanil or pethidine.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||78|
|- Interventions||Standard therapy will consist of routine conscious sedation with midazolam (7.5 mg per os) and pethidine (2 mg/kg bodyweight i.m.). Both medications will be administered 30 minutes before the puncture procedure. Since the half-life of pethidine is 3-5 hours, post-puncture analgesia will start when patients are at home.
The investigational treatment consists of continuous intravenous remifentanil administration of 0.05 microgram/kg/minute with the possibility of self-administration of a remifentanil bolus with a dosage of 0.5 microgram/kg per bolus and a lock out of 2 minutes. Remifentanil infusion will start 5 minutes before oocyte retrieval. Since remifentanil has a very short half-life, the analgesic effect of remifentanil will disappear within 5 minutes after the end of remifentanil infusion. The remifentanil infusion will therefore be preceded by preemptive administration of diclofenac (50 mg sup.) for treatment of post-puncture pain 60 minutes before the start of oocyte retrieval.
|- Primary outcome||1. Pain levels and as measured by 0-10 numeric rating scale (NRS);|
2. SpO2, heart rate and blood pressure during oocyte retrieval;
3. Pain levels in the first 4 days post-puncture.
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||1. Difference in pain between patients with or without endometriosis;|
2. Difference in puncture pain between left- and right ovary;
3. Pain predictors including the expected pain levels, anxiety and pre-procedure pain;
4. Pain scores in the first 4 days post-puncture;
5. Level of sedation according to the Ramsey sedation scale;
6. Use of post-puncture pain medication;
7. Pregnancy rate;
8. Treatment costs;
9. Patient satisfaction with the analgesic method.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Christa Boer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Christa Boer|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Oocyte retrieval for in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) as infertility treatments is commonly obtained by ultrasound-guided, transvaginal puncture of the ovaries, which is unpleasant and painful for the patient. Although most patients tolerate the procedure well, oocyte retrieval may even be associated with severe visceral pain in a small percentage of patients, especially in patients suffering from endometriosis. In the VU University Medical Center, oocyte retrieval is currently performed under intramuscular pethidine analgesia in combination with light, conscious sedation using an oral short-acting benzodiazepine midazolam (Dormicum® 7,5mg). However, the analgesic efficacy of pethidine has only been scarcely investigated and the single-dose regime for pethidine is not always sufficient to provide optimal pain relief during oocyte retrieval. Remifentanil is a synthetic opioid with an ultra-short half-life characterized by a rapid onset of action and short latency to its peak effect and may be used for patient controlled analgesia. Currently there are no studies available evaluating the use of remifentanil in patient-controlled analgesia during oocyte retrieval. Furthermore, this analgesic technique has only been scarcely evaluated in comparison with intravenous administration of pethidine. The current study therefore aims to compare the analgesic efficacy and safety of remifentanil versus pethidine in the relief of puncture pain during oocyte retrieval. |
|- Main changes (audit trail)|
|- RECORD||27-jul-2010 - 21-okt-2011|