Clinical trial NCT06039761: Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery
Official title: Randomized Study Comparing the Combination Intraperitoneal Local Anesthetics, Maneuvers Alveolar Recruitment and Abdominal Compression Compared to Passive Exsufflation of the Pneumoperitoneum in the Prevention of Pain Shoulders After Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-09-15
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study patients will be divided into 2 arms (1:1) and will benefit from one of the following procedures:

* Arm A (experimental): Overall procedure = standard procedure + local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver.
* Arm B (control): Standard procedure.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder pain at rest assessed by visual analog scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Hôpital Privé Dijon Bourgogne
Study officials:
References: