A Phase 3 interventional study of Ropivacaine 60 mg and Ropivacaine 100 mg in Laparoscopic Cholecystectomy, sponsored by San Gerardo Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-11-25.
Sponsored by San Gerardo Hospital · Phase 3, Interventional, and Treatment
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.
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.
San Gerardo Hospital is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Instillation of Ropivacaine 100 mg in the abdominal cavity
Drug: Ropivacaine 100 mg
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
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
Postoperative Pain
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.
Time frame: 48 hours
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
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.
Time frame: Up to 48 hours
Time to hospital discharge
We define hospital stay as the elapsed time between surgery and hospital discharge
Time frame: 48 hours
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Gerardo Hospital