Status:
COMPLETED
Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Shoulder Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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. Compara...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06039761
Start Date
December 13 2023
End Date
September 30 2024
Last Update
March 27 2025
Active Locations (1)
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1
Hôpital Privé Dijon Bourgogne
Dijon, France, 21000