Clinical trial NCT02467985: A Trial to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
Official title: FIGARO : A Double-blinded RCT to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: gynecological laparoscopic surgery
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: shoulder pain
timeFrame: 48 hours
Secondary outcomes:
measure: The impact of referred pain in the shoulder
timeFrame: 48 hours
measure: The intensity of abdominal pain Postoperatively
timeFrame: 48 hours
measure: The incidence of postoperative nausea
timeFrame: 48 hours
measure: The quality of life
timeFrame: 48 hours
measure: Theincidence of abdominal pain Postoperatively
timeFrame: 48 hours
measure: The incidence of postoperative vomiting
timeFrame: 48 hours
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Jean-Charles Pasquier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: