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Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?

Phase 3
18 Years
65 Years
Not Enrolling
Ovarian Cysts

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Trial Information

Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?

In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or
after gynaecologic laparoscopic surgery significantly reduces postoperative pain and
postoperative morphine consumption.

Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®).

However, almost all patients still use morphine after surgery.

The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may
prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Inclusion Criteria:

- Females 18-65 years old

- ASA Score I-III

- Scheduled for ovarian cyst laparoscopic surgery

- Free from pain in preoperative period

- Not using analgesic drugs before surgery

- Without cognitive impairment or mental retardation

- Written informed consent

Exclusion Criteria:

- Emergency/urgency surgery

- Postoperative admission in an intensive care unit

- Cognitive impairment or mental retardation

- Progressive degenerative diseases of the CNS

- Seizures 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Morphine consumption (mg)

Outcome Description:

The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display.

Outcome Time Frame:

Up to 24 hours

Safety Issue:


Principal Investigator

Pablo M Ingelmo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Gerardo Hospital, Monza. Italy


Italy: Ethics Committee

Study ID:

AR HSG 02 2010 Ovarian Cyst



Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cysts
  • Ovarian Cysts
  • Nebulization
  • Ropivacaine
  • Ovarian Cysts