Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery (POPPLaS)

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: Digestive or gynecological surgery by laparoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien DECHANET, MD; Phone Number: +33 6 12 85 91 37; Email: dechanet.fabien@hotmail.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Hôpital Privé Dijon Bourgogne
    • Contact: Fabien DECHANET, MD; Phone Number: +33 6 12 85 91 37; Email: dechanet.fabien@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver; Overall Procedure : The specific interventions are carried out at the end of the surgical intervention and include the use of intraperitoneal local anesthetics insufflated by the surgeon, the alveolar recruitment maneuver carried out by the anesthetist and that of abdominal compression carried out by the surgeon.	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
Active Comparator: Standard Procedure; Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2023-A01281-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No