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Completed

NCT Number: NCT06039761

Randomized Study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Dijon Bourgogne

Dijon, 21000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digestive or gynecological surgery by laparoscopy

Procedure

Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia

Primary outcomes

  1. Shoulder pain at rest assessed by visual analog scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study 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

Acronym: POPPLaS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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