MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

NCT00853177 | Completed Phase 4 DMC

• 1 other identifier: P070304
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain after oocyte retrieval at + 30, 60 and 120 minutes.

  immediate (at + 30, 60 and 120 minutes)

Secondary Outcomes (3)

• Patients satisfaction at time + 120 minutes.

  immediate (at + 120 minutes)

• Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes.

  immediate (at time + 120 minutes)

• Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid.

  immediate

Study Arms (2)

nitrous oxide

EXPERIMENTAL

N2O of 50% and 50% O2 MEOPA

Procedure: MEOPA inhalation

lidocaine

ACTIVE COMPARATOR

Injection solution 1%

Procedure: xylocaine

Interventions

MEOPA inhalation PROCEDURE

N2O of 50% and 50% O2

nitrous oxide

xylocaine PROCEDURE

Ampoule-bottle of 20 ml

Also known as: local anesthesia

lidocaine

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient requiring a first or second oocyte retrieval procedure for IVR or ICSI after ovarian stimulation by gonadotrophin
• agreement to participate to this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Bondy, Île-de-France Region, 93143, France

Location

Related 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. doi: 10.2165/00002512-200724060-00006.

  PMID: 17571915 RESULT

Related Links

• PubMed

MeSH Terms

Conditions

Infertility; Pain

Interventions

Lidocaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Christophe Poncelet, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: March 2, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 18, 2012

Record last verified: 2011-05

Locations

FR (1)