Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT06039761
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2023-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery
Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPPLaS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: