SurgeryFIGARONCT02467985
A Trial to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
A study testing FIGARO in people with Surgery, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Surgery
- What is being tested?
- FIGARO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Valérie Lanctôt, MD contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Jean-Charles Pasquier, Md,PhD
About this study
Official title: FIGARO : A Double-blinded RCT to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
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.
- Conditions
- Surgery
- Being tested
- FIGARO
- Keywords
- gynecological laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIGAROProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| 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. Receives: Procedure: FIGARO |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder pain
questionnaire
Measured: 48 hours
Secondary outcomes (6)
The impact of referred pain in the shoulder
questionnaire
Measured: 48 hours
The intensity of abdominal pain Postoperatively
questionnaire
Measured: 48 hours
The incidence of postoperative nausea
questionnaire
Measured: 48 hours
The quality of life
questionnaire
Measured: 48 hours
Theincidence of abdominal pain Postoperatively
questionnaire
Measured: 48 hours
The incidence of postoperative vomiting
questionnaire
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
- Investigators
- Jean-Charles Pasquier, MD, PhD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467985
- Sponsor's protocol ID
- 2015-1042
- Acronym
- FIGARO
- Status last verified
- Jul 2017
- First submitted
- 11 May 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIGARO : A Double-blinded RCT to Reduce Referred Pain in the Shoulder Following a Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02467985
- Acronym / sponsor ID
- FIGARO / 2015-1042
- Conditions
- Surgery
- Keywords
- gynecological laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| intervention | Experimental | Procedure: FIGAROFlow 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- physical ASA score 3-4
- pregnant women
- chronic pain syndrome or preoperative pain syndrome
- narcotics consumption, chronic preoperative analgesia
- alcohol or drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIGAROflow 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. | Procedure or surgery | intervention |
Primary outcome
shoulder pain
Time frame: 48 hours
questionnaire
6 secondary outcomes
The impact of referred pain in the shoulder
Time frame: 48 hours
The intensity of abdominal pain Postoperatively
Time frame: 48 hours
The incidence of postoperative nausea
Time frame: 48 hours
The quality of life
Time frame: 48 hours
Theincidence of abdominal pain Postoperatively
Time frame: 48 hours
The incidence of postoperative vomiting
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Lanctôt, MD contact
Jean-Charles Pasquier, MD, PhD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIGARO in people with Surgery, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie Gillet, MSc (819-346-1110 ext. 13877, Virginie.Gillet@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.