MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)
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Purpose
The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility Pain |
Procedure: MEOPA inhalation Procedure: xylocaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study |
- Pain after oocyte retrieval at + 30, 60 and 120 minutes. [ Time Frame: immediate (at + 30, 60 and 120 minutes) ] [ Designated as safety issue: Yes ]
- Patients satisfaction at time + 120 minutes. [ Time Frame: immediate (at + 120 minutes) ] [ Designated as safety issue: Yes ]
- Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes. [ Time Frame: immediate (at time + 120 minutes) ] [ Designated as safety issue: Yes ]
- Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid. [ Time Frame: immediate ] [ Designated as safety issue: Yes ]
| Enrollment: | 77 |
| Study Start Date: | November 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nitrous oxide
N2O of 50% and 50% O2 MEOPA |
Procedure: MEOPA inhalation
N2O of 50% and 50% O2
Other Name: MEOPA inhalation
|
|
Active Comparator: lidocaine
Injection solution 1%
|
Procedure: xylocaine
Ampoule-bottle of 20 ml
Other Name: local anesthesia
|
Detailed Description:
Oocyte retrieval is a major event during in VITRO-fertilization, with or without sperm micro-injection. Initially done by laparoscopy with general anesthesia, the oocyte collection is now carried out by trans-vaginal controlled ultrasound puncture. This potential painful event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary, requires analgesia or anesthesia. General anesthesia is certainly effective in terms of collected oocytes. It remains, however, a heavy time consumer, with personal risks and distributor of anesthetic agents in blood or follicular fluid. These products could have a deleterious effect on early embryonic development or implantation. Few data are available concerning these risks in the literature. General anesthesia is still essential for pusillanimous patients or for patients with a heavy surgical past. Nitrous oxide is an inhaled gas with properties widely used in obstetric during parturition. It is regularly used during general anesthesia performed for oocyte retrieval. With a gas composed of 50% N2O and 50% O2, its main interest is to provide analgesia in a state of conscious sedation. The effects of nitrous oxide in this form had never been assessed on the clinical or biological Oocyte collection. We conducted a preliminary study to assess pain in patients receiving local anesthesia, according the current protocol. Thus, 44% of patients had severe pain (VAS> 40/100) during or just after transvaginal oocyte retrieval. In our preliminary experience, immediate or distance post-operative pain was high and we plan to evaluate the benefit of analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective, randomized and controlled study as compared with local anesthesia associated to Alprazolam.
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patient requiring a first or second oocyte retrieval procedure for IVR or ICSI after ovarian stimulation by gonadotrophin
- agreement to participate to this study
Exclusion Criteria:
- absolute indication for oocyte retrieval with general anesthesia
- no agreement to participate to this study,
- painfully known patient-not easy ovarian vaginal accessibility for monitoring or puncture
- respiratory pathology-chronic liver, kidney pathology, immunodeficiency, -contraindication to the medications used during the protocol
Contacts and Locations| France | |
| Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet | |
| Bondy, Ile de France, France, 93143 | |
| Principal Investigator: | Christophe Poncelet, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
Additional Information:
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00853177 History of Changes |
| Other Study ID Numbers: | P070304 |
| Study First Received: | February 6, 2009 |
| Last Updated: | September 15, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Oocyte retrieval pain surgery anaesthesiology Assisted Reproductive Technologies |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Anesthetics Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013