Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

San Gerardo Hospital

Status and phase: Terminated; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine 150 mg; Drug: saline 15 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01432496

AR HSG 06 2010 Colectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

Ropivacaine 150 mg

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 150 mg

Saline 15 ml

Placebo Comparator group

Description:

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

Treatment:

Drug: saline 15 ml