Shoulder Pain Clinical Trial
— POPPLaSOfficial 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
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Privé Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
GCS Ramsay Santé pour l'Enseignement et la Recherche |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder pain at rest assessed by visual analog scale | 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. |
1 day |
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