Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

NCT06039761 | Completed

• 1 other identifier: 2023-A01281-44
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Procedure: Digestive or gynecological surgery by laparoscopy

Interventions

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

Standard Procedure; local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Digestion

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to the result of the randomization, unlike the investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: December 13, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

FR (1)