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Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

This study has been terminated.
(There was insuficient recruitment in two centers)
Sponsor:
Collaborators:
University of Milano Bicocca
Azienda Ospedaliera di Lecco
IRCCS Policlinico S. Matteo
University of Pavia
Information provided by (Responsible Party):
Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01432496
First received: September 9, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
 Drug: Ropivacaine 150 mg
Drug: saline 15 ml
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 72 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.

  • Return to active bowel function [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.

  • Hospital morbidity [ Time Frame: 72 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

  • Time and condition for hospital discharge [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Time in days elapsed between surgery and hospital discharge.

  • Analgesic consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display


Estimated Enrollment: 130
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system
 Drug: Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity
Other Name: Nebulization Ropivacaine
Placebo Comparator: Saline 15 ml
Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system
 Drug: saline 15 ml
Nebulization of saline 15 ml in the peritoneal cavity
Other Name: Nebulization Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432496

Locations
Italy
Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
Lecco, LC, Italy, 23900
San Gerardo Hospital
Monza, MB, Italy, 20052
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100
Sponsors and Collaborators
San Gerardo Hospital
University of Milano Bicocca
Azienda Ospedaliera di Lecco
IRCCS Policlinico S. Matteo
University of Pavia
Investigators
Principal Investigator: Pablo M Ingelmo, MD San Gerardo Hospital, MB, Italy
  More Information

Publications:

Responsible Party: Pablo Mauricio Ingelmo M.D., Consultant Anesthesiologys. First Service of Anesthesia and Intensive Care, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01432496     History of Changes
Other Study ID Numbers: AR HSG 06 2010 Colectomy
Study First Received: September 9, 2011
Last Updated: February 22, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by San Gerardo Hospital:
Laparoscopic
Colectomy
Nebulization
Ropivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 May 23, 2013