Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

San Gerardo Hospital

Status and phase: Completed; Phase 3

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: Ropivacaine 100 mg; Drug: Ropivacaine 50 mg; Drug: Ropivacaine 150 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01143025

AR HSG 01 2010

Details and patient eligibility

About

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg, 100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic cholecystectomy.

Full description

Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has been proved to significantly reduce postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting in comparison with patients receiving direct instillation of Bupivacaine 50 mg or placebo.

Ropivacaine can be effectively administrated with non-heating nebulizers (AeronebPro®). In a recent study our group found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy significantly reduced postoperative pain and morphine consumption. Nonetheless, most patients still need strong opioid based analgesia after surgery.

We hypothesize that intraperitoneal nebulization of Ropivacaine 100 mg and 150 mg (maximum recommended dose in adults 300 mg or up to 3 mg/kg) may prevent the use of morphine during the first day after surgery maintaining ropivacaine plasma levels below toxic concentration.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females and Males 18-75 years old
• ASA Score I-III
• Scheduled for laparoscopic cholecystectomy
• Free from pain in preoperative period
• Not using analgesic drugs before surgery
• Without cognitive impairment or mental retardation
• Written informed consent

Exclusion criteria

• Emergency/urgency surgery
• Postoperative admission in an intensive care unit
• Cognitive impairment or mental retardation
• Progressive degenerative diseases of the CNS
• Seizures or chronic therapy with antiepileptic drugs
• Severe hepatic or renal impairment
• Pregnancy or lactation
• Allergy to one of the specific drugs under study
• Acute infection or inflammatory chronic disease
• Alcohol or drug addiction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 3 patient groups

Ropivacaine 50 mg

Active Comparator group

Description:

Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity

Treatment:

Drug: Ropivacaine 50 mg

Ropivacaine 100 mg

Experimental group

Description:

Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity

Treatment:

Drug: Ropivacaine 100 mg

Ropivacaine 150 mg

Experimental group

Description:

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Treatment:

Drug: Ropivacaine 150 mg