Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
Study NCT ID:
NCT06753292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-laparoscopic shoulder pain by VAS score', 'timeFrame': '24 hours', 'description': 'post-laparoscopic shoulder pain by VAS score'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary recruitment maneuver', 'active gas aspiration'], 'conditions': ['Post Laparoscopic Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '37752263', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30014331', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35426396', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 .\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 18- 65 years.\n\n * American Society of Anesthesiologists physical status classification (ASA) I - II\n * scheduled for an elective gyncologic laparoscopic procedures\n\nExclusion Criteria:\n\n* • Urgent or emergency case.\n\n * ASA classification more than III.\n * Age less than 16 years.\n * Reduced left and right ventricular function (ejection fraction \\<40%).\n * Previous respiratory disease such as chronic obstructive pulmonary disease, restrictive lung disease, or had a history of thoracic or shoulder surgery\n * Patient conversion to a laparotomy.\n * the operation time is more than 3 h'}, 'identificationModule': {'nctId': 'NCT06753292', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'pulm recruit gas aspir Gyn lap'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'The surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas', 'interventionNames': ['Procedure: active gas aspiration']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'The surgeon will be instructed to apply PRM pressures. patients will receive the PRM which consisted of five manual pulmonary inflations,', 'interventionNames': ['Procedure: pulmonary recruitment maneuver']}], 'interventions': [{'name': 'active gas aspiration', 'type': 'PROCEDURE', 'description': 'surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas', 'armGroupLabels': ['group 1']}, {'name': 'pulmonary recruitment maneuver', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Essam Salama Hammam, resident doctor', 'role': 'CONTACT', 'email': 'mahmoudhamam98@icloud.com', 'phone': '+201098209345\u202c\u202c\u202c\u202c'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at Assiut University hospital', 'investigatorFullName': 'Mahmoud Essam Salama Hammam', 'investigatorAffiliation': 'Assiut University'}}}}