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Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

Information source: San Gerardo Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cysts

Intervention: Ropivacaine nebulization (Drug); Ropivacaine instillation (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: San Gerardo Hospital

Official(s) and/or principal investigator(s):
Pablo M Ingelmo, MD, Principal Investigator, Affiliation: San Gerardo Hospital, Monza. Italy


The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

Clinical Details

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

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

Primary outcome: Morphine consumption (mg)

Secondary outcome:

Postoperative Pain

Time of unassisted walking

Hospital morbidity

Hospital stay

Quality of life after surgery

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.


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

Locations and Contacts

San Gerardo Hospital, Monza, MB 20052, Italy
Additional Information

Related publications:

Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c.

Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16.

Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18.

Starting date: April 2010
Last updated: February 22, 2013

Page last updated: August 23, 2015

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