Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

Shoulder Pain Clinical Trial

— POPPLaS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039761
• Other study ID #: 2023-A01281-44
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Shoulder Pain

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