The Influence of Combining the Pulmonary Recruitment Maneuver with Active Gas Aspiration on Post-laparoscopic Shoulder Pain in Patients Having a Gynecologic Laparoscopy, Randomized Double Blinded Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Post Laparoscopic Shoulder Pain

• Registration Number: NCT06753292
• Lead Sponsor: Assiut University

Brief Summary

Laparoscopy is among the most used minimally invasive procedures that can reduce postoperative pain, lessen the duration of hospital stay and facilitate recovery. Laparoscopy has been widely used in various abdominal surgeries, such as gastrectomy, cholecystectomy, appendectomy, hernia and gynecological surgery . However, the post-laparoscopic shoulder pain (PLSP) often occurs following laparoscopic surgeries, and its reported incidence varies from 35-80% This study aims to assess the effect of combining pulmonary recruitment maneuvers (PRM) with active gas aspiration on post-laparoscopic shoulder pain in patients undergoing gynecological laparoscopic procedures.

Detailed Description

The PLSP can even remain for up to three days and often upsets the patients . Moreover, it can increase the costs of healthcare owing to an increased usage of analgesics, delayed discharge, and even re-admission .

Therefore, necessary measures should be taken to diminish the intensity of PLSP. Although the exact mechanism of PLSP remains unclear, some studies have suggested that it is caused by the trapping of carbon dioxide (CO2) between the liver and the right diaphragm and subsequent conversion into carbonic acid, which irritates the diaphragm and subsequently generates referred shoulder pain (C4 dermatomal) . Therefore, several studies have attempted to decrease the incidence or severity of PLSP by promoting the removal of remaining CO2 from the abdominal cavity. These efforts include drainage tube insertion, intraperitoneal saline instillation (IPSI), and the usage of intraperitoneal local anesthetic agents . More-over, the pulmonary recruitment maneuver (PRM) can also facilitate the removal of CO2 from the abdominal cavity by increasing positive airway pressure and intrathoracic pressure. PRM is more commonly used in clinical practice because it does not require drugs, specialized apparatus, or additional medical costs, unlike the other methods . Several trials have described the advantages of PRM in patients undergoing laparoscopic operations compared to passive abdominal compression.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• • Age 18- 65 years.

  • American Society of Anesthesiologists physical status classification (ASA) I - II
  • scheduled for an elective gyncologic laparoscopic procedures

Exclusion Criteria

• • Urgent or emergency case.

  • ASA classification more than III.
  • Age less than 16 years.
  • Reduced left and right ventricular function (ejection fraction <40%).
  • Previous respiratory disease such as chronic obstructive pulmonary disease, restrictive lung disease, or had a history of thoracic or shoulder surgery
  • Patient conversion to a laparotomy.
  • the operation time is more than 3 h

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
post-laparoscopic shoulder pain by VAS score	24 hours	post-laparoscopic shoulder pain by VAS score