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临床试验/NCT02467985
NCT02467985Unknown不适用

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

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
175
试验地点
1
主要终点
shoulder pain

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women, 18-65 years
  • physical ASA score 1-2
  • Elective laparoscopic surgery for benign cause
  • patients who have been informed of the study and has agreed to sign the ICF

排除标准

  • physical ASA score 3-4
  • pregnant women
  • chronic pain syndrome or preoperative pain syndrome
  • narcotics consumption, chronic preoperative analgesia
  • alcohol or drug dependence
  • inability to provide telephone follow up at 48 hours
  • laparoscopy not possible at the umbilical level.

研究组 & 干预措施

Control

No Intervention

intervention

Experimental

Flow of insufflation will be set to 2-3L / min. After the intervention, the CO2 insufflation is discontinued, accessories trocars are removed under direct vision and the incisions the sites of these trocars will be closed. Patients will be placed in the Trendelenburg position 30 degrees, head tilted down. The umbilical trocar is opened. Suction is inserted into the trocar, taking care to stay inside the jacket of the trocar. Active suction gas will during lung recruitment. This maneuver will be performed by the anesthesiologist who applies 5 subsequent forced breaths, up to 40 cm H2O pressure, taking care to maintain the insufflation last 5 sec. Once completed, the suction will be removed, the laparoscope is inserted into the trocar to verify the absence of trauma to underlying structures.

干预措施: FIGARO (Procedure)

结局指标

主要结局

shoulder pain

时间窗: 48 hours

questionnaire

次要结局

  • The impact of referred pain in the shoulder(48 hours)
  • The intensity of abdominal pain Postoperatively(48 hours)
  • Theincidence of abdominal pain Postoperatively(48 hours)
  • The incidence of postoperative nausea(48 hours)
  • The quality of life(48 hours)
  • The incidence of postoperative vomiting(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Charles Pasquier, MD, PhD

full professor

Université de Sherbrooke

研究点 (1)

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