Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

Phase 3

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: Ropivacaine 150 mg; Drug: saline 15 ml

• Registration Number: NCT01432496
• Lead Sponsor: San Gerardo Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 150 mg	Ropivacaine 150 mg	Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system
Saline 15 ml	saline 15 ml	Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

San Gerardo Hospital; 🇮🇹 Monza, MB, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, PV, Italy

Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"; 🇮🇹 Lecco, LC, Italy