Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery (POPPLaS)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Shoulder Pain

Treatments: Procedure: Digestive or gynecological surgery by laparoscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06039761

2023-A01281-44

Details and patient eligibility

About

The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on Day 1.

Full description

This is an interventional, comparative, controlled, randomized, single-blind study (the patient will be blinded to the result of the randomization, unlike the investigator) and single-center.

Comparative prospective cohort study of laparoscopic surgery with the addition of specific non-surgical interventions aimed at preventing postoperative shoulder pain (use of local intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver abdominal) versus without specific interventions aimed at preventing post-operative shoulder pain.

All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia provided in the usual setting of laparoscopic surgery.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years;
• Celiosurgery including a Transversus Abdominis Plane block with multimodal analgesia;
• Planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia, incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation;
• Affiliation to the social security scheme;
• Signed informed consent

Exclusion criteria

• Celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy, nephrectomy;
• Surgical emergency;
• History of chronic obstructive pulmonary disease;
• Weight less than 50 kg;
• Consumption of preoperative opioids;
• Antidepressant treatment and/or anxiolytic treatment;
• Conversion by laparotomy;
• Intraperitoneal sepsis;
• Major intraoperative complication (hemorrhage, anaphylaxis, etc.);
• Other surgical or medical interventions planned during the study;
• Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
• Inability to understand information related to the study;
• Woman who is pregnant or likely to be pregnant (of childbearing age, without effective contraception) or currently breastfeeding;
• Patient deprived of liberty or under guardianship or curatorship or unable to give consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver

Experimental group

Description:

Overall Procedure : The specific interventions are carried out at the end of the surgical intervention and include the use of intraperitoneal local anesthetics insufflated by the surgeon, the alveolar recruitment maneuver carried out by the anesthetist and that of abdominal compression carried out by the surgeon.

Treatment:

Procedure: Digestive or gynecological surgery by laparoscopy

Standard Procedure

Active Comparator group

Description:

Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia.

Treatment:

Procedure: Digestive or gynecological surgery by laparoscopy