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Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ropivacaine 150 mg
saline 15 ml
Sponsored by
San Gerardo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Laparoscopic, Colectomy, Nebulization, Ropivacaine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females and Males 18-80 years old
  • ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
  • ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
  • ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
  • Patients scheduled for oncological laparoscopic colectomy
  • Patients who do not use opioids analgesic drugs before surgery
  • Patients without cognitive impairment or mental retardation

Exclusion Criteria:

  • Females and Males under 18 or over 80
  • ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
  • ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
  • Emergency/urgency surgery
  • Postoperative admission in an intensive care unit with sedation or ventilatory assistance
  • Cognitive impairment or mental retardation
  • Use of opiods before surgery
  • Progressive degenerative diseases of the CNS
  • Convulsions or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Allergy to one of the specific drugs under study
  • Acute infection or inflammatory chronic disease
  • Alcohol or drug addiction
  • Any kind of communication problem
  • Neurologic or psychiatric disease

Sites / Locations

  • Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
  • San Gerardo Hospital
  • Fondazione IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine 150 mg

Saline 15 ml

Arm Description

Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system

Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system

Outcomes

Primary Outcome Measures

Postoperative pain
Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.

Secondary Outcome Measures

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.
Return to active bowel function
The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.
Hospital morbidity
All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified
Time and condition for hospital discharge
Time in days elapsed between surgery and hospital discharge.
Analgesic consumption
The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display

Full Information

First Posted
September 9, 2011
Last Updated
February 22, 2013
Sponsor
San Gerardo Hospital
Collaborators
University of Milano Bicocca, Azienda Ospedaliera di Lecco, IRCCS Policlinico S. Matteo, University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT01432496
Brief Title
Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
Official Title
A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
There was insuficient recruitment in two centers
Study Start Date
September 2011 (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
University of Milano Bicocca, Azienda Ospedaliera di Lecco, IRCCS Policlinico S. Matteo, University of Pavia

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 produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
Detailed Description
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo. In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery. The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated. The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Laparoscopic, Colectomy, Nebulization, Ropivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine 150 mg
Arm Type
Experimental
Arm Description
Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system
Arm Title
Saline 15 ml
Arm Type
Placebo Comparator
Arm Description
Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 150 mg
Other Intervention Name(s)
Nebulization Ropivacaine
Intervention Description
Nebulization of Ropivacaine 150 mg in the peritoneal cavity
Intervention Type
Drug
Intervention Name(s)
saline 15 ml
Other Intervention Name(s)
Nebulization Saline
Intervention Description
Nebulization of saline 15 ml in the peritoneal cavity
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.
Time Frame
72 hours
Secondary Outcome Measure Information:
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
72 hours
Title
Return to active bowel function
Description
The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.
Time Frame
72 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
Time Frame
72 hours
Title
Time and condition for hospital discharge
Description
Time in days elapsed between surgery and hospital discharge.
Time Frame
72 hours
Title
Analgesic consumption
Description
The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females and Males 18-80 years old ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient. ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease Patients scheduled for oncological laparoscopic colectomy Patients who do not use opioids analgesic drugs before surgery Patients without cognitive impairment or mental retardation Exclusion Criteria: Females and Males under 18 or over 80 ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation Emergency/urgency surgery Postoperative admission in an intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Use of opiods before surgery Progressive degenerative diseases of the CNS Convulsions or chronic therapy with antiepileptic drugs Severe hepatic or renal impairment Allergy to one of the specific drugs under study Acute infection or inflammatory chronic disease Alcohol or drug addiction Any kind of communication problem Neurologic or psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo M Ingelmo, MD
Organizational Affiliation
San Gerardo Hospital, MB, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Facility Name
San Gerardo Hospital
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Citations:
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
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
background
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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Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

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