Aerosolized intraperitoneal local anesthetic for laparoscopic surgery: a randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Postoperative pain remains a significant challenge following laparoscopy. Aerosolized intraperitoneal local anesthetic (AILA) is a novel method to deliver local anesthetic. The aim was to evaluate aerosolized ropivacaine in pain management following laparoscopic Nissen fundoplication (LNF) and cholecystectomy (LC). METHODS: This prospective randomized double-blinded placebo-controlled trial enrolled consecutive patients undergoing LNF and LC. The treatment group (TG) received intraperitoneal ropivacaine (5 mL 1 % Naropin(®)) at CO2 insufflation via the AeroSurge(®) aerosolizer device through the camera port. The control group (CG) received 5 mL of saline in the same manner. Postoperative shoulder tip pain at rest 6 h postoperatively was the primary study endpoint, with secondary endpoints of shoulder and abdominal pain within the first 24 h, recovery room stay, hospital stay, and postoperative analgesia use. Pain scores were collected using the Verbal Rating Score. RESULTS: Eighty-seven patients were included in the final analysis (TG n = 40, CG n = 47). There was no significant difference between CG and TG at the primary endpoint. In the LC group, AILA significantly reduced shoulder tip pain at rest at 10 (p = 0.030) and 30 min (p = 0.040) and shoulder tip pain on movement at 10 (p = 0.030) and 30 min (p = 0.037). In the LNF group, AILA significantly reduced postoperative abdominal pain at rest at 6 h (p = 0.009). AILA reduced overall incidence of shoulder tip pain in the LC group (11.8 vs. 57.9 %, p = 0.004). CONCLUSION: This study did not demonstrate a significant difference between TG and CG in the primary endpoint, pain at 6 h postoperatively.

Total systemic ropivacaine concentrations following aerosolized intraperitoneal delivery using the AeroSurge.

STUDY OBJECTIVE: To evaluate intraperitoneal ropivacaine delivery with the AeroSurge device in the clinical setting and to evaluate the total systemic ropivacaine levels achieved following delivery of 50 mg of aerosolized ropivacaine. DESIGN: Preliminary, prospective, nonrandomized study. SETTING: Operating room of a university hospital. PATIENTS: 5 consecutive ASA physical status 1 and 2 patients undergoing elective laparoscopic Nissen fundoplication or cholecystectomy. INTERVENTION: Five mL of 1% ropivacaine was delivered through the 10 mm port using the AeroSurge device at peritoneal insufflation. MEASUREMENTS: Venous blood samples were collected and total ropivacaine concentration was determined using liquid chromatography-mass spectrometry. MAIN RESULTS: The AeroSurge device delivered ropivacaine, visible as mist within the peritoneal cavity. Peak concentration (Cmax) was attained between 10 and 30 minutes following the end of aerosolized ropivacaine delivery. At no stage did any level approach toxic levels. CONCLUSIONS: This preliminary study confirms that aerosolized intraperitoneal local anesthetic is feasible, with ropivacaine concentrations remaining within safe levels.