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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039761

Collaborator

(none)

190

Enrollment

Location

Arms

Anticipated Duration (Months)

31.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Procedure: Digestive or gynecological surgery by laparoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study patients will be divided into 2 arms (1:1) and will benefit from one of the following procedures: Arm A (experimental): Overall procedure = standard procedure + local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver. Arm B (control): Standard procedure.Study patients will be divided into 2 arms (1:1) and will benefit from one of the following procedures:Arm A (experimental): Overall procedure = standard procedure + local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver. Arm B (control): Standard procedure.

Masking:

Single (Participant)

Masking Description:

The patient will be blinded to the result of the randomization, unlike the investigator.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Shoulder pain at rest assessed by visual analog scale [1 day]
Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCS Ramsay Santé pour l'Enseignement et la Recherche

ClinicalTrials.gov Identifier:

NCT06039761

Other Study ID Numbers:

2023-A01281-44

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Pain

Study Results

No Results Posted as of Sep 15, 2023