Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery
|Laparoscopic Cholecystectomy||Drug: Ropivacaine 60 mg Drug: Ropivacaine 100 mg||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Intraperitoneal Nebulization of Ropivacaine With Intraperitoneal Instillation of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy|
- Postoperative Pain [ Time Frame: 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.
- Morphine consumption (mg) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 hours ]We define hospital stay as the elapsed time between surgery and hospital discharge
|Study Start Date:||April 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Instillation
Instillation of Ropivacaine 100 mg in the abdominal cavity
Drug: Ropivacaine 100 mg
Instillation group received intraperitoneal instillation of ropivacaine 0.5%, 20 ml (100 mg) on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus and intraperitoneal nebulization of normal saline 3 ml before the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum. The first saline nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
Nebulization of Ropivacaine 60 mg in the abdominal cavity
Drug: Ropivacaine 60 mg
Nebulization grou received intraperitoneal instillation of saline 20 ml on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum (total of 60 mg). The first ropivacaine nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248819
|San Gerardo Hospital|
|Monza, MB, Italy, 20052|
|Principal Investigator:||Pablo M Ingelmo, MD||San Gerardo Hospital|