MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00853177
First received: February 6, 2009
Last updated: September 15, 2012
Last verified: May 2011

February 6, 2009
September 15, 2012
November 2008
January 2011   (final data collection date for primary outcome measure)
Pain after oocyte retrieval at + 30, 60 and 120 minutes. [ Time Frame: immediate (at + 30, 60 and 120 minutes) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00853177 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 Reactiv Oxygen Species in retrieved follicular fluid. [ Time Frame: immediate ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility
  • Pain
  • Procedure: MEOPA inhalation
    N2O of 50% and 50% O2
    Other Name: MEOPA inhalation
  • Procedure: xylocaine
    Ampoule-bottle of 20 ml
    Other Name: local anesthesia
  • Experimental: nitrous oxide

    N2O of 50% and 50% O2

    MEOPA

    Intervention: Procedure: MEOPA inhalation
  • Active Comparator: lidocaine
    Injection solution 1%
    Intervention: Procedure: xylocaine
Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00853177
P070304
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Christophe Poncelet, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP