The main objective of this open-label, randomized clinical trial is to asses whether patient-controlled analgesia with remifentanil is more efficious and equally safe as pethidine as analgesic strategy during ultrasound-guided transvaginal oocyte…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The major endpoint of our trail is a reduction in pain levels as measured by a
10-point VAS during oocyte retrieval through transvaginal puncture.
Secondary outcome
Secondary endpoint of our trial will be: (if applicable)
-difference between patient with or without endometriosis,
-difference in puncture pain between left- or right ovary,
-pain scores in the first three days post-puncture,
-factors on influence on puncture pain,
-level of sedation,
-level of nausea during analgesia,
-use of post-puncture medication,
-IVF-related success parameters,
-treatment costs,
-patients* satisfaction with the analgesic method.
Other study parameters: (if applicable)
-Patients* demographics
Background 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 intravenous pethidine analgesia in combination with
light, conscious sedation using a short-acting benzodiazepine. 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
systemic administration of pethidine. The current study therefore aims to
compare the analgesic efficacy and safety of remifentanil versus pethidine in
the treatment of puncture pain during oocyte retrieval.
Study objective
The main objective of this open-label, randomized clinical trial is to asses
whether patient-controlled analgesia with remifentanil is more efficious and
equally safe as pethidine as analgesic strategy during ultrasound-guided
transvaginal oocyte retrieval.
Study design
Open-label, randomized clinical trial.
The study will be performed at the VU University Medical Center.
Female patients undergoing IVF/ICSI in the VU University Medical Center will be
included.
Female subjects will be recruited by the attending gynaecologist in the period
before the IVF/ICSI procedure. The IVF/ICSI procedure will be performed
according to routine clinical practice as is performed in the VU University
Medical Center.
Informed consent will be asked at least 24 hours before the measurements take
place.
Patients will be randomized into one of both analgesic treatment groups before
undergoing the routine oocyte retrieval procedure. After the retrieval
procedure, patients will be asked to fill a pain and discomfort diary in the
following three days. Medication-related side effects will also be monitored.
The study will end when the acquired sample size is reached.
Intervention
The investigational treatment consists of continuous intravenous remifentanil
administration of 0.05 microram/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 paracetamol (1 gram per os) in
combination with diclofenac (50 mg per os) for treatment of post-puncture pain
60 minutes before the start of oocyte retrieval.
Study burden and risks
There are no serious adverse events expected since all procedures are standard
clinical care.
By suppression of puncture pain by pethidine (i.m.) in combination with
midazolam the occurrence of drowsiness and nausea may be increased. These risks
are however minimal. Moreover, since pethidine is only once provided the
analgesic efficacy may be insufficient to relief transvaginal puncture pain.
Remifentanil will be provided through patient-controlled analgesia, which
implies the insertion of an intravenous catheter that will be removed after the
puncture procedure. Remifentanil may affect blood pressure and SpO2, which will
be closely monitored by the attending physician. In case of unexpected SpO2
changes, 100% oxygen will be provided
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Female subjects who undergo elective IVF/ICSI
- Age 18-45 years
- Informed consent
Exclusion criteria
- Not willing to receive analgesia
- Allergy for remifentanil or pethidine
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019074-32-NL |
| CCMO | NL31643.029.10 |