Shoulder PainPOPPLaSNCT06039761
Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery
A study testing Digestive or gynecological surgery by laparoscopy in people with Shoulder Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Digestive or gynecological surgery by laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Digestive or gynecological surgery by laparoscopy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive or gynecological surgery by laparoscopyProcedure or surgery
Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia
| Study group | Role | What they receive |
|---|---|---|
| local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver | Experimental | 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. Receives: Procedure: Digestive or gynecological surgery by laparoscopy |
| Standard Procedure | Active comparator | Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia. Receives: Procedure: Digestive or gynecological surgery by laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start13 Dec 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039761
- Sponsor's protocol ID
- 2023-A01281-44
- Acronym
- POPPLaS
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039761
- Acronym / sponsor ID
- POPPLaS / 2023-A01281-44
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver | Experimental | Procedure: Digestive or gynecological surgery by laparoscopyOverall 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 | Active comparator | Procedure: Digestive or gynecological surgery by laparoscopyStandard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digestive or gynecological surgery by laparoscopyDigestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia | Procedure or surgery | Standard Procedure, local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive or gynecological surgery by laparoscopy in people with Shoulder Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain at rest assessed by visual analog scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.