Effects of intraperitoneal nebulization in laparoscopic surgery

Active, not recruiting

Conditions: Elective videolaparoscopic hysterectomy
MedDRA version: 14.0Level: HLGTClassification code 10046828Term: Uterine, pelvic and broad ligament disordersSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2010-019830-29-IT

Lead Sponsor: Hopitaux Universitaires de Strasbourg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Female

Target Recruitment: 248

Inclusion Criteria

Patient older than 18 years ASA<3 Patient scheduled for elective laparoscopic hysterectomy Not urgency surgery Signed of informed consent
Are the trial subjects under 18?
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patient younger than 18 years ASA>3 Pregnancy or lactation Usage of alcohol or drugs Chronic inflammatory state Chronic algic syndrome No possibility of 6 days after surgery follow up Refuse of the patient Neurological, psychiatric or communication problems

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Evaluation of inflammatory parameters, quality of life, hospitalization time and visual comfort of the surgeon.;Primary end point(s): Entity of postoperative pain and loss of temperature;Timepoint(s) of evaluation of this end point: 48 h;Main Objective: Asses if preoperative nebulization of Ropivacaine (135 mg) comparing with preoperative instillation of Ropivacaine (135 mg) diminish the intensity of postoperative pain and the decreasing of central body temperature in laparoscopic surgery.

Secondary Outcome Measures