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

Surgery Clinical Trial

— FIGARO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02467985
• Other study ID #: 2015-1042
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: July 18, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Université de Sherbrooke
• Contact: Virginie Gillet, MSc
• Phone: 819-346-1110
• Email: Virginie.Gillet[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Referred
• Surgery

Intervention

Procedure:
• FIGARO
flow of insufflation set to 2-3L / min. Once the intervention is complete, the CO2 insufflation is discontinued, accessories trocars are removed under direct vision and the incisions the sites of these trocars will be closed with or without fascial closure according to the standard display. Patients will be placed in the Trendelenburg position 30 degrees, head tilted down. The umbilical trocar is opened. A 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 apply 5 subsequent forced breaths, up to 40 cm H2O pressure, taking care to maintain the insufflation last 5 seconds. Once completed, the suction will be removed, the laparoscope is inserted into the trocar to verify the absence of trauma to underlying structures. The patient will be given to neutral at the end of the procedure.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shoulder pain	questionnaire	48 hours
Secondary	The impact of referred pain in the shoulder	questionnaire	48 hours
Secondary	The intensity of abdominal pain Postoperatively	questionnaire	48 hours
Secondary	The incidence of postoperative nausea	questionnaire	48 hours
Secondary	The quality of life	questionnaire	48 hours
Secondary	Theincidence of abdominal pain Postoperatively	questionnaire	48 hours
Secondary	The incidence of postoperative vomiting	questionnaire	48 hours