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Peritoneal nebulization of Ropivacaine for postoperative pain control after laparoscopic cholecystectomy A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 100 mg or 150 mg with preoperative peritoneal nebulization of Ropivacaine 50 mg in the peritoneal cavity - AR HSG 01 2010

Peritoneal nebulization of Ropivacaine for postoperative pain control after laparoscopic cholecystectomy A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 100 mg or 150 mg with preoperative peritoneal nebulization of Ropivacaine 50 mg in the peritoneal cavity - AR HSG 01 2010

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018247-24-IT
Enrollment
Unknown
Registered
2010-03-29
Start date
2010-03-04
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Elective Laparoscopic cholecystectomy MedDRA version: 12.1 Level: LLT Classification code 10008611 Term: Cholecystectomy

Interventions

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

Sponsors

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Females and Males 18-75 years old; ASA Score I-III; severe systemic disease; patients scheduled for laparoscopic cholecystectomy; 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Females and Males under 18 or over 75; 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; no written informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate if preoperative nebulization of Ropivacaine 100 mg or 150 mg compared with preoperative nebulization of Ropivacaine 50 mg prevent the use of morphine after laparoscopic cholecystectomy;Secondary Objective: Ropivacaine plasma concentration and pharmacokinetics profile; Postoperative pain intensity; Time to unassisted walking; Incidence of adverse events; Time and condition for hospital discharge; Quality of life during the first four week 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