NCT01142622

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

June 9, 2010

Last Update Submit

February 22, 2013

Conditions

Ovarian Cysts

Keywords

Ovarian CystsNebulizationRopivacaine

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption (mg)

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

    Up to 24 hours

Secondary Outcomes (5)

  • Postoperative Pain

    Up to 24 hours

  • Time of unassisted walking

    Up to 24 hours

  • Hospital morbidity

    Up to 24 hours

  • Hospital stay

    Up to 24 hours

  • Quality of life after surgery

    Four weeks after surgery

Study Arms (2)

Ropivacaine nebulization

EXPERIMENTAL

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Drug: Ropivacaine nebulization

Ropivacaine instillation

ACTIVE COMPARATOR

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery

Drug: Ropivacaine instillation

Interventions

Ropivacaine nebulizationDRUG

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.

Also known as: Ropivacaine, Nebulization
Ropivacaine nebulization
Ropivacaine instillationDRUG

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Also known as: Ropivacaine, Instillation
Ropivacaine instillation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gerardo Hospital

Monza, MB, 20052, Italy

Location

Related Publications (3)

  • 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.

    PMID: 18633034BACKGROUND

  • 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. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.

    PMID: 17180268BACKGROUND

  • 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.

    PMID: 18347861BACKGROUND

MeSH Terms

Conditions

Ovarian Cysts

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pablo M Ingelmo, MD

    San Gerardo Hospital, Monza. Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologyst

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

IT(1)