MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

Pain Clinical Trial

— KALOVAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853177
• Other study ID #: P070304
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2009
• Last updated: September 15, 2012
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Pain

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet	Bondy	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after oocyte retrieval at + 30, 60 and 120 minutes.		immediate (at + 30, 60 and 120 minutes)	Yes
Secondary	Patients satisfaction at time + 120 minutes.		immediate (at + 120 minutes)	Yes
Secondary	Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes.		immediate (at time + 120 minutes)	Yes
Secondary	Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid.		immediate	Yes

External Links

•   PubMed