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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753292
Enrollment
120
Registered
2024-12-31
Start date
2025-01-01
Completion date
2026-03-01
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Laparoscopic Shoulder Pain

Keywords

pulmonary recruitment maneuver, active gas aspiration

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.

Interventions

surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas

patients will receive the PRM which consisted of five manual pulmonary inflations, where each positive pressure inflation will be done for 5 s at a maximum pressure of 30 cm H2O, manually by using the APL valve in the anesthesia machine. The patient will be in a Trendelenburg position (30°). The fifth positive pressure inflation lasted for approximately 5 s. During that time, the patient will be closely monitored, while the anesthesiologist performed PRM

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
post-laparoscopic shoulder pain by VAS score24 hourspost-laparoscopic shoulder pain by VAS score

Contacts

Primary ContactMahmoud Essam Salama Hammam, resident doctor
mahmoudhamam98@icloud.com+201098209345‬‬‬‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026