Marta Somaini1, Pietro Brambillasca2, Pablo Mauricio Ingelmo3, Federica Lovisari4, Stefano Scalia Catenacci4, Valeria Rossini5, Mario Bucciero6, Emre Sahillioglu7, Alessandro Buda8, Mauro Signorelli8, Mauro Gili4, Girish Joshi9, Roberto Fumagalli10, Catherine E Ferland11, Pierre Diemunsch12. 1. U.O. Anestesia e Rianimazione 1, Ospedale Niguarda Ca' Granda, Milan, Italy. 2. U.O. Anestesia e Rianimazione I, Ospedale Riuniti di Bergamo, Bergamo, Italy. 3. McGill University Health Centre, Montreal Children's Hospital, Montreal, Canada. Electronic address: pablo.ingelmo@muhc.mcgill.ca. 4. U.O. Anestesia e Rianimazione, Ospedale San Gerardo, Monza, Italy. 5. Università degli Studi Milano Bicocca, Milan, Italy. 6. Service d'Anesthésie Réanimation, Hôpital Lariboisière, Paris, France. 7. Department of Anesthesia and Intensive Care, Kozyatağı Acıbadem Hospital, İstanbul, Turkey. 8. U.O. Ginecologia e Ostetricia, Ospedale San Gerardo, Monza, Italy. 9. Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas. 10. U.O. Anestesia e Rianimazione 1, Ospedale Niguarda Ca' Granda, Milan, Italy; Università degli Studi Milano Bicocca, Milan, Italy. 11. McGill University Health Centre, Montreal Children's Hospital, Montreal, Canada. 12. Service d'Anesthésiologie-Réanimation Chirurgicale, CHU de Hautepierre, and EA 3072, Faculté de Médecine, Strasbourg, France.
Abstract
STUDY OBJECTIVE: To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain controlafter gynecologic laparoscopy. DESIGN: Evidence obtained from a properly designed, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING: Tertiary care center. PATIENTS: One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy. INTERVENTION: Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery (preoperative group), nebulization of 30 mg ropivacaine after surgery (postoperative group), instillation of 100 mg ropivacaine before surgery (instillation group), or instillation of saline solution (control group). Nebulization was performed using the Aeroneb Pro device. MEASUREMENT AND MAIN RESULTS:Pain scores, morphine consumption, and ambulation time were collected in the post-anesthesia care unit and at 4, 6, and 24 hours postoperatively. One hundred eighteen patients completed the study. Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group (net difference 2 points; 95% confidence interval [CI], 0.3-3.1 at 4 hours, 1-3 at 6 hours, and 0.7-3 at 24 hours; p = .01) Patients in the preoperative group consumed significantly less morphine than did those in the control group (net difference 7 mg; 95% CI, 0.7-13; p = .02). More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups (net difference 15%; 95% CI, 6%-24%; p = .001). CONCLUSIONS: Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance.
RCT Entities:
STUDY OBJECTIVE: To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain control after gynecologic laparoscopy. DESIGN: Evidence obtained from a properly designed, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING: Tertiary care center. PATIENTS: One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy. INTERVENTION: Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery (preoperative group), nebulization of 30 mg ropivacaine after surgery (postoperative group), instillation of 100 mg ropivacaine before surgery (instillation group), or instillation of saline solution (control group). Nebulization was performed using the Aeroneb Pro device. MEASUREMENT AND MAIN RESULTS:Pain scores, morphine consumption, and ambulation time were collected in the post-anesthesia care unit and at 4, 6, and 24 hours postoperatively. One hundred eighteen patients completed the study. Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group (net difference 2 points; 95% confidence interval [CI], 0.3-3.1 at 4 hours, 1-3 at 6 hours, and 0.7-3 at 24 hours; p = .01) Patients in the preoperative group consumed significantly less morphine than did those in the control group (net difference 7 mg; 95% CI, 0.7-13; p = .02). More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups (net difference 15%; 95% CI, 6%-24%; p = .001). CONCLUSIONS: Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance.