Clinical Trial: A Trial to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: FIGARO : A Double-blinded RCT to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery

Brief Summary: Patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the shoulder in the first days following their intervention. Pain can be disabling and may even delay the discharge of patients. Several techniques have been proposed to reduce this problem. Promising strategies include the reduction of CO2 insufflation flow, lung recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical procedure to force gas discharge. The investigators wish to perform a randomized controlled trial with 160 women, who will assess the effect of a combined approach, combining for the first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the Trendelenburg position at the end of surgery and flow of insufflation reduces carbon dioxide (CO2) forming the pneumoperitoneum during surgery, on the intensity of shoulder pain postoperatively. In the control group the evacuation of the pneumoperitoneum will be done by opening the trocars and external abdominal pressure at the end of surgery. No study to our knowledge has tested the active aspiration maneuvers gas after laparoscopic surgery in gynecology. The study will be preceded by a pilot study in 15 participants, who will be assigned to the control group to determine the basic rate of referred pain in the shoulder in our people and improve test management.

Detailed Summary:
Sponsor: Université de Sherbrooke

Current Primary Outcome: shoulder pain [ Time Frame: 48 hours ]

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Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The impact of referred pain in the shoulder [ Time Frame: 48 hours ]
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  • The intensity of abdominal pain Postoperatively [ Time Frame: 48 hours ]
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  • The incidence of postoperative nausea [ Time Frame: 48 hours ]
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  • The quality of life [ Time Frame: 48 hours ]
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  • Theincidence of abdominal pain Postoperatively [ Time Frame: 48 hours ]
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  • The incidence of postoperative vomiting [ Time Frame: 48 hours ]
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Original Secondary Outcome: Same as current

Information By: Université de Sherbrooke

Dates:
Date Received: May 11, 2015
Date Started: April 2015
Date Completion: December 2017
Last Updated: June 5, 2015
Last Verified: June 2015