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

Primary Purpose

Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Digestive or gynecological surgery by laparoscopy
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital Privé Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver

Standard Procedure

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT06039761
Brief Title
Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
The patient will be blinded to the result of the randomization, unlike the investigator.
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Procedure
Arm Type
Active Comparator
Arm Description
Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia.
Intervention Type
Procedure
Intervention Name(s)
Digestive or gynecological surgery by laparoscopy
Intervention Description
Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia
Primary Outcome Measure Information:
Title
Shoulder pain at rest assessed by visual analog scale
Description
Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien DECHANET, MD
Phone
6 12 85 91 37
Ext
+33
Email
dechanet.fabien@hotmail.fr
Facility Information:
Facility Name
Hôpital Privé Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien DECHANET, MD
Phone
6 12 85 91 37
Ext
+33
Email
dechanet.fabien@hotmail.fr

12. IPD Sharing Statement

Learn more about this trial

Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

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