Trial record 5 of 356 for:    Ovarian Cysts: Ovarian Cysts

Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

This study has been completed.
Sponsor:
Collaborator:
A.O. Ospedale Papa Giovanni XXIII
Information provided by (Responsible Party):
Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01142622
First received: June 9, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cysts
Drug: Ropivacaine nebulization
Drug: Ropivacaine instillation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • Morphine consumption (mg) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display.


Secondary Outcome Measures:
  • Postoperative Pain [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain, back pain and shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.

  • Time of unassisted walking [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.

  • Hospital morbidity [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]
    All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia, will be quantified using the anesthesia charts, surgical charts and surgical database.

  • Hospital stay [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    We define hospital stay as the time in hours elapsed between surgery and hospital discharge. We evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS).

  • Quality of life after surgery [ Time Frame: Four weeks after surgery ] [ Designated as safety issue: No ]
    Quality of life will be assessed using the SF-36 questionnaire


Estimated Enrollment: 140
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Drug: Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
Other Names:
  • Ropivacaine
  • Nebulization
Active Comparator: Ropivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery
Drug: Ropivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
Other Names:
  • Ropivacaine
  • Instillation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142622

Locations
Italy
San Gerardo Hospital
Monza, MB, Italy, 20052
Sponsors and Collaborators
San Gerardo Hospital
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Pablo M Ingelmo, MD San Gerardo Hospital, Monza. Italy
  More Information

Publications:
Responsible Party: Pablo Mauricio Ingelmo M.D., Consultant Anesthesiologyst, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01142622     History of Changes
Other Study ID Numbers: AR HSG 02 2010 Ovarian Cyst
Study First Received: June 9, 2010
Last Updated: February 22, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by San Gerardo Hospital:
Ovarian Cysts
Nebulization
Ropivacaine

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Ovarian Diseases
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014