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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06039761
Other study ID # 2023-A01281-44
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2023
Est. completion date September 30, 2024

Study information

Verified date May 2024
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact Fabien DECHANET, MD
Phone 6 12 85 91 37
Email dechanet.fabien@hotmail.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
France Hôpital Privé Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

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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