J Sroussi1, A Elies2, A Rigouzzo3, N Louvet3, M Mezzadri2, A Fazel4, J-L Benifla2. 1. Department of Gynecology and Obstetrics, Lariboisière Hospital, 2, rue Ambroise-Paré, 75010 Paris, France; Department of Gynecology and Obstetrics, Trousseau Hospital, 26, avenue du Dr-A.-Netter, 75012 Paris, France. Electronic address: jeremy.sroussi@gmail.com. 2. Department of Gynecology and Obstetrics, Lariboisière Hospital, 2, rue Ambroise-Paré, 75010 Paris, France; Department of Gynecology and Obstetrics, Trousseau Hospital, 26, avenue du Dr-A.-Netter, 75012 Paris, France. 3. Department of Anesthesiology and Intensive Care, Trousseau Hospital, 26, avenue du Dr-A.-Netter, 75012 Paris, France. 4. Department of Gynecology and Obstetrics, Lariboisière Hospital, 2, rue Ambroise-Paré, 75010 Paris, France.
Abstract
OBJECTIVES: To evaluate feasibility of performing benign gynecologic pathology low pressure (7mmHg) laparoscopy (LPL) with AirSeal® system and to study benefits in terms of postoperative pain, when compared to a standard insufflation group (15mmHg). MATERIALS AND METHODS: In this prospective randomized pilot study, 60 patients had laparoscopy for gynecologic benign pathology: 30 with 7mmHg and AirSeal system, and 30 with 15mmHg standard insufflator. The primary endpoint was incidence of shoulder pain. A postoperative questionnaire was completed by each patient to assess shoulder pain (Numeric Rating Scale [NRS], from 0 to 10) at H4, H8, H24, and consumption of morphinics was notified. During each procedure, anesthesia parameters were collected (peak airway pressure, systolic blood pressure, end tidal CO2). RESULTS:Laparoscopy was performed on 30 patients in AirSeal®-LP group without need to increase pressure above 7mmHg, and no complication was reported. Incidence of shoulder pain was significantly lower in the AirSeal®-LP group (23.3% vs. 73.3%, P<0.001). NRS shoulder pain was significantly lower in AirSeal®LP group at hour 4, 8 and 24. Maximal values of ETCO2, systolic blood pressure, and peak airway pressure were significantly lower in AirSeal®-LP group. CONCLUSION:LP (7mmHg) laparoscopy with AirSeal® platform allows laparoscopic surgery with less postoperative shoulder pain. These results could facilitate the development of ambulatory laparoscopy.
RCT Entities:
OBJECTIVES: To evaluate feasibility of performing benign gynecologic pathology low pressure (7mmHg) laparoscopy (LPL) with AirSeal® system and to study benefits in terms of postoperative pain, when compared to a standard insufflation group (15mmHg). MATERIALS AND METHODS: In this prospective randomized pilot study, 60 patients had laparoscopy for gynecologic benign pathology: 30 with 7mmHg and AirSeal system, and 30 with 15mmHg standard insufflator. The primary endpoint was incidence of shoulder pain. A postoperative questionnaire was completed by each patient to assess shoulder pain (Numeric Rating Scale [NRS], from 0 to 10) at H4, H8, H24, and consumption of morphinics was notified. During each procedure, anesthesia parameters were collected (peak airway pressure, systolic blood pressure, end tidal CO2). RESULTS: Laparoscopy was performed on 30 patients in AirSeal®-LP group without need to increase pressure above 7mmHg, and no complication was reported. Incidence of shoulder pain was significantly lower in the AirSeal®-LP group (23.3% vs. 73.3%, P<0.001). NRS shoulder pain was significantly lower in AirSeal® LP group at hour 4, 8 and 24. Maximal values of ETCO2, systolic blood pressure, and peak airway pressure were significantly lower in AirSeal®-LP group. CONCLUSION:LP (7mmHg) laparoscopy with AirSeal® platform allows laparoscopic surgery with less postoperative shoulder pain. These results could facilitate the development of ambulatory laparoscopy.
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