Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

NCT ID: NCT06039761

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2024-09-30

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver

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.

Group Type: EXPERIMENTAL

Digestive or gynecological surgery by laparoscopy

Intervention Type: PROCEDURE

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

Standard Procedure

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

Group Type: ACTIVE_COMPARATOR

Digestive or gynecological surgery by laparoscopy

Intervention Type: PROCEDURE

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

Interventions

Digestive or gynecological surgery by laparoscopy

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

2023-A01281-44

Identifier Type: -

Identifier Source: org_study_id