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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
165
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
San Gerardo Hospital
Monza, MB, Italy
Morphine consumption (mg)
The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display
Time frame: Up to 48 hours
Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine
We will perform a pharmacokinetic analysis through venous samples collected at 20, 40, 60, 90, 240, and 360 minutes after the end of nebulization.
Time frame: Up to 360 minutes
Ropivacaine pharmacokinetics profile: Tissue drug analysis
Tissue samples (at least 2 g of tissue) from parietal peritoneum will be taken at the end of surgery . The supernatant will be analised with mass-spectrometry
Time frame: Up to 2 hours
Postoperative Pain
Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain and/or shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS \< 3) will also be assessed.
Time frame: Up to 48 hours
Time of unassisted walking
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.
Time frame: Up to 48 hours
Hospital morbidity
All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified using the anesthesia charts, surgical charts, surgical database.
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Time frame: Up to 48 hours
Time and condition for hospital discharge
We define hospital stay as the elapsed time between surgery and hospital discharge, in days. We also evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS).
Time frame: Up to 48 hours
Quality of life after surgery
Quality of life will be assessed using the SF-36 questionnaire
Time frame: Four weeks after surgery