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

Primary Purpose

Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FIGARO
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring gynecological laparoscopic surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

shoulder pain
questionnaire

Secondary Outcome Measures

The impact of referred pain in the shoulder
questionnaire
The intensity of abdominal pain Postoperatively
questionnaire
The incidence of postoperative nausea
questionnaire
The quality of life
questionnaire
Theincidence of abdominal pain Postoperatively
questionnaire
The incidence of postoperative vomiting
questionnaire

Full Information

First Posted
May 11, 2015
Last Updated
July 18, 2017
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02467985
Brief Title
A Trial to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
Acronym
FIGARO
Official Title
FIGARO : A Double-blinded RCT to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
gynecological laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FIGARO
Intervention Description
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.
Primary Outcome Measure Information:
Title
shoulder pain
Description
questionnaire
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
The impact of referred pain in the shoulder
Description
questionnaire
Time Frame
48 hours
Title
The intensity of abdominal pain Postoperatively
Description
questionnaire
Time Frame
48 hours
Title
The incidence of postoperative nausea
Description
questionnaire
Time Frame
48 hours
Title
The quality of life
Description
questionnaire
Time Frame
48 hours
Title
Theincidence of abdominal pain Postoperatively
Description
questionnaire
Time Frame
48 hours
Title
The incidence of postoperative vomiting
Description
questionnaire
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie Gillet, MSc
Phone
819-346-1110
Ext
13877
Email
Virginie.Gillet@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Lanctôt, MD
Email
valerie.lanctot@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Pasquier, MD, PhD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Pasquier, Md,PhD

12. IPD Sharing Statement

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

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