MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

Official Title: “MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study”

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.

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.

Intervention(s) in this Clinical Trial

• Procedure: MEOPA inhalation
  • N2O of 50% and 50% O2
• Procedure: xylocaine
  • Ampoule-bottle of 20 ml

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: nitrous oxide
  • N2O of 50% and 50% O2 MEOPA
• Active Comparator: lidocaine
  • Injection solution 1%

Primary Measures

• Pain after oocyte retrieval at + 30, 60 and 120 minutes.
  • Time Frame: immediate (at + 30, 60 and 120 minutes)
    Safety Issue?: Yes

Secondary Measures

• Patients satisfaction at time + 120 minutes.
  • Time Frame: immediate (at + 120 minutes)
    Safety Issue?: Yes
• Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes.
  • Time Frame: immediate (at time + 120 minutes)
    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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 42 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Assistance Publique - Hôpitaux de Paris Other

Overall Clinical Trial Officials and Contacts

Christophe Poncelet, MD PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00853177

Study ID Number: P070304

ClinicalTrials.gov Identifier: NCT00853177

Health Authority: France: Ministry of Health

PubMed