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Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

Primary Purpose

Ovarian Cysts

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ropivacaine nebulization
Ropivacaine instillation
Sponsored by
San Gerardo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cysts focused on measuring Ovarian Cysts, Nebulization, Ropivacaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Gerardo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ropivacaine nebulization

Ropivacaine instillation

Arm Description

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative Pain
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
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
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
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
Quality of life will be assessed using the SF-36 questionnaire

Full Information

First Posted
June 9, 2010
Last Updated
February 22, 2013
Sponsor
San Gerardo Hospital
Collaborators
A.O. Ospedale Papa Giovanni XXIII
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1. Study Identification

Unique Protocol Identification Number
NCT01142622
Brief Title
Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
Official Title
Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Gerardo Hospital
Collaborators
A.O. Ospedale Papa Giovanni XXIII

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts
Keywords
Ovarian Cysts, Nebulization, Ropivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine nebulization
Arm Type
Experimental
Arm Description
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Arm Title
Ropivacaine instillation
Arm Type
Active Comparator
Arm Description
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine nebulization
Other Intervention Name(s)
Ropivacaine, Nebulization
Intervention Description
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine instillation
Other Intervention Name(s)
Ropivacaine, Instillation
Intervention Description
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
Primary Outcome Measure Information:
Title
Morphine consumption (mg)
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.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
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 Frame
Up to 24 hours
Title
Time of unassisted walking
Description
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.
Time Frame
Up to 24 hours
Title
Hospital morbidity
Description
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.
Time Frame
Up to 24 hours
Title
Hospital stay
Description
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).
Time Frame
Up to 24 hours
Title
Quality of life after surgery
Description
Quality of life will be assessed using the SF-36 questionnaire
Time Frame
Four weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo M Ingelmo, MD
Organizational Affiliation
San Gerardo Hospital, Monza. Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Gerardo Hospital
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18633034
Citation
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.
Results Reference
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PubMed Identifier
17180268
Citation
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.
Results Reference
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PubMed Identifier
18347861
Citation
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.
Results Reference
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Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

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