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Do peritoneal nebulization of Ropivacaine reduce the use of morphine after short gynecologic laparoscopic surgery? A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 150 mg with preoperative peritoneal instillation of Ropivacaine 150 mg in the peritoneal cavity. - AR HSG 02 2010

Do peritoneal nebulization of Ropivacaine reduce the use of morphine after short gynecologic laparoscopic surgery? A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 150 mg with preoperative peritoneal instillation of Ropivacaine 150 mg in the peritoneal cavity. - AR HSG 02 2010

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018693-20-IT
Enrollment
Unknown
Registered
2010-03-22
Start date
2010-03-18
Completion date
Unknown
Last updated
2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective ovarian cyst laparoscopic surgery MedDRA version: 9.1 Level: PT Classification code 10033132

Interventions

Trade Name: NAROPINA Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-

Sponsors

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Females 18-65 years old; ASA Score I III; Patients scheduled for ovarian cyst laparoscopic surgery; Free from pain in preoperative period; Patients who do not use analgesic drugs before surgery; Patients without cognitive impairment or mental retardation; Patients who have given a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Females under 18 or over 65; ASA IV V; Emergency/urgency surgery; Postoperative admission in an intensive care unit with sedation or ventilatory assistance; Cognitive impairment or mental retardation; Use of analgesic drugs before surgery; Progressive degenerative diseases of the CNS; Convulsions or chronic therapy with antiepileptic drugs; Severe hepatic or renal impairment; Pregnancy or lactation; Allergy to one of the specific drugs under study; Acute infection or inflammatory chronic disease; Alcohol or drug addiction; Any kind of communication problem; Neurologic or psychiatric disease

Design outcomes

Primary

MeasureTime frame
Main Objective: Asses if preoperative nebulization of Ropivacaine (150 mg) comparing with preoperative instillation of Ropivacaine (150 mg) reduced the use of morphine in the first day after ovarian cyst laparoscopic surgery;Secondary Objective: Intensity of Postoperative Pain; Time of unassisted walking; Incidence of adverse events; Time and condition for hospital discharge; Quality of life four weeks after surgery;Primary end point(s): Morphine consumption—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026