Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery
- Conditions
- Laparoscopic Cholecystectomy
- Interventions
- Registration Number
- NCT01248819
- Lead Sponsor
- San Gerardo Hospital
- Brief Summary
Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after laparoscopic cholecystectomy.
- Detailed Description
Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic cholecystectomy have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. A recent study reported that bupivacaine nebulization significantly reduced pain after laparoscopic cholecystectomy compared with bupivacaine instillation in the gallbladder bed. However, these investigators used a custom-made nebulization system that needs a separate gas source and tubing that is cumbersome and may not be easily available.
Recently, the investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief after laparoscopic cholecystectomy than intraperitoneal ropivacaine instillation. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization using the Aeroneb Pro® device laparoscopic cholecystectomy compared with intraperitoneal ropivacaine instillation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Instillation Ropivacaine 100 mg Instillation of Ropivacaine 100 mg in the abdominal cavity Nebulization Ropivacaine 60 mg Nebulization of Ropivacaine 60 mg in the abdominal cavity
- Primary Outcome Measures
Name Time Method Postoperative Pain 48 hours Postoperative pain was assessed by Visual analgue scale (VAS 0 to 100 points) at rest (static VAS) and after a deep inspiration or cough (dynamic VAS). The proportion of patients with adequate pain control after surgery (dynamic VAS \< 3) will also be assessed.
- Secondary Outcome Measures
Name Time Method Morphine consumption (mg) Up to 48 hours 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 of unassisted walking Up to 48 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.
Hospital morbidity Up to 48 hours 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.
Time to hospital discharge 48 hours We define hospital stay as the elapsed time between surgery and hospital discharge
Trial Locations
- Locations (1)
San Gerardo Hospital
🇮🇹Monza, MB, Italy