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

NCT02467985 | Unknown DMC

• 1 other identifier: 2015-1042
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

gynecological laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• shoulder pain

  questionnaire

  48 hours

Secondary Outcomes (6)

• The impact of referred pain in the shoulder

  48 hours

• The intensity of abdominal pain Postoperatively

  48 hours

• The incidence of postoperative nausea

  48 hours

• The quality of life

  48 hours

• Theincidence of abdominal pain Postoperatively

  48 hours

Study Arms (2)

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.

Procedure: FIGARO

Interventions

FIGARO PROCEDURE

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.

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Study Officials

• Jean-Charles Pasquier, MD, PhD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie Gillet, MSc

CONTACT

819-346-1110; Virginie.Gillet@usherbrooke.ca

Valérie Lanctôt, MD

CONTACT

valerie.lanctot@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 10, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

CA (1)