Shoulder Pain
Conditions
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.
Interventions
PROCEDUREDigestive 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
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient will be blinded to the result of the randomization, unlike the investigator.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain at rest assessed by visual analog scale | 1 day | Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm. ANCOVA (Analysis of Covariance) analysis will be applied to compare the mean shoulder pain visual analog scal (0 to 100 mm) between the groups, adjusted to the baseline value. |
Countries
France
Outcome results
None listed