Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Ropivacaine 60 mg; Ropivacaine 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy; Nebulization; Ropivacaine