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
NCT ID: NCT06753292
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-01-01
2026-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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group 1
The surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
active gas aspiration
surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
group 2
The surgeon will be instructed to apply PRM pressures. patients will receive the PRM which consisted of five manual pulmonary inflations,
pulmonary recruitment maneuver
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
Interventions
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active gas aspiration
surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
pulmonary recruitment maneuver
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
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status classification (ASA) I - II
* scheduled for an elective gyncologic laparoscopic procedures
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Essam Salama Hammam
resident doctor at Assiut University hospital
Central Contacts
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Mahmoud Essam Salama Hammam, resident doctor
Role: CONTACT
Phone: +201098209345
Email: [email protected]
References
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Samarah BM, Shehada FA, Qaddumi J, Almasry NA, Alhroub N, ALBashtawy B, Mohammad K, ALBashtawy S, Alkhawaldeh A, ALBashtawy M, Al Omari O, Aljezawi M, Hamadneh S, Suliman M, Hani SB, ALBashtawy Z. The influence of the pulmonary recruitment maneuver on post-laparoscopic shoulder pain in patients having a laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2023 Nov;37(11):8473-8482. doi: 10.1007/s00464-023-10450-x. Epub 2023 Sep 26.
Ryu KH, Lee SH, Cho EA, Kim JA, Lim GE, Song T. Comparison of impacts of intraperitoneal saline instillation with and without pulmonary recruitment maneuver on post-laparoscopic shoulder pain prevention: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):870-878. doi: 10.1007/s00464-018-6354-2. Epub 2018 Jul 16.
Demouron M, Selvy M, Dembinski J, Mauvais F, Cheynel N, Slim K, Sabbagh C, Regimbeau JM. Feasibility and Effectiveness of an Enhanced Recovery Program after Early Cholecystectomy for Acute Calculous Cholecystitis: A 2-Step Study. J Am Coll Surg. 2022 May 1;234(5):840-848. doi: 10.1097/XCS.0000000000000123.
Other Identifiers
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pulm recruit gas aspir Gyn lap
Identifier Type: -
Identifier Source: org_study_id