Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

Sponsor

San Gerardo Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01432496

Collaborator

University of Milano Bicocca (Other), Azienda Ospedaliera di Lecco (Other), IRCCS Policlinico S. Matteo (Other), University of Pavia (Other)

130

Enrollment

Locations

Arms

Duration (Months)

43.3

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Ropivacaine 150 mg Drug: saline 15 ml	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Nebulization Saline

Arm

Intervention/Treatment

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 Names:

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 Names:

Nebulization Saline

Outcome Measures

Primary Outcome Measures

Postoperative pain [72 hours]
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 [72 hours]
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 [72 hours]
The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.
Hospital morbidity [72 hours]
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 [72 hours]
Time in days elapsed between surgery and hospital discharge.
Analgesic consumption [72 hours]
The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"	Lecco	LC	Italy	23900
2	San Gerardo Hospital	Monza	MB	Italy	20052
3	Fondazione IRCCS Policlinico San Matteo	Pavia	PV	Italy	27100