MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

NCT ID: NCT00853177

Last Updated: 2012-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-01-31

Brief 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.

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.

Conditions

Infertility; Pain

Keywords

Oocyte retrieval; pain; surgery; anaesthesiology; Assisted Reproductive Technologies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nitrous oxide

N2O of 50% and 50% O2

MEOPA

Group Type: EXPERIMENTAL

MEOPA inhalation

Intervention Type: PROCEDURE

N2O of 50% and 50% O2

lidocaine

Injection solution 1%

Group Type: ACTIVE_COMPARATOR

xylocaine

Intervention Type: PROCEDURE

Ampoule-bottle of 20 ml

Interventions

MEOPA inhalation

N2O of 50% and 50% O2

Intervention Type: PROCEDURE

xylocaine

Ampoule-bottle of 20 ml

Intervention Type: PROCEDURE

Other Intervention Names

local anesthesia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Poncelet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet

Bondy, Île-de-France Region, France

Countries

France

References

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. doi: 10.2165/00002512-200724060-00006.

Reference Type: RESULT

PMID: 17571915 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/17571915?ordinalpos=2&itool=Entrez

PubMed

Other Identifiers

P070304

Identifier Type: -

Identifier Source: org_study_id