Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04642118
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2020-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder pain from using PRM 30 cmH2O', 'timeFrame': 'During stay in hospital around 2-3 days', 'description': 'To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 30 cmH2O group and control group at 12, 24 and 48 hrs.'}], 'secondaryOutcomes': [{'measure': 'wound pain', 'timeFrame': 'During stay in hospital around 2-3 days', 'description': 'evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)'}, {'measure': 'shoulder pain from using PRM 40 cmH2O', 'timeFrame': 'During stay in hospital around 2-3 days', 'description': 'To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 40 cmH2O group and control group at 12, 24 and 48 hrs.'}, {'measure': 'Post-operative residue pneumoperitoneum', 'timeFrame': 'after surgery in day 1', 'description': 'Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright'}, {'measure': 'Lung complication', 'timeFrame': 'after surgery in day 1', 'description': 'Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded'}, {'measure': 'GI discomfort', 'timeFrame': 'during stay in hospital around 2-3 days', 'description': 'number of symptom'}, {'measure': 'Time to hospital staying', 'timeFrame': 'During stay in hospital around 2-3 days', 'description': 'record day which stay in hospital with abnormal condition'}, {'measure': 'Administered additional analgesics', 'timeFrame': 'During stay in hospital around 2-3 days', 'description': 'number of morphine using'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low pressure', 'Pulmonary Recruitment Maneuver', 'Post-laparoscopic Shoulder Pain'], 'conditions': ['Gynecologic Disease', 'Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative residual pneumoperitoneum, lung complication, GI discomfort, administered additional analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure 30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in Rajavithi hospital.', 'detailedDescription': "Research design is Randomized control trial. The women who go to laparoscopic gynecologic surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40 cmH2O and control\n\nAfter laparoscopic surgery has finished in operator room (before moving off trocar), woman all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.\n\nThe patients in group of using Pulmonary Recruitment Maneuver will be received positive pressure from balloon bag from anesthesiologist 5 times of setting pressure \\[30 cmH2O, 40 cmH2O\\], 5 seconds per time to increase indirect abdominal pressure to release residual gas\n\nAfter surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung complication. GI discomfort, administered additional analgesics and time to hospital staying will be evaluated and recorded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Anesthesiologists physical status (ASAPS) classification I-II\n* Absence of Pregnancy\n* With inform-consent\n\nExclusion Criteria:\n\n* Inability to accurately express pain\n* Past history of shoulder or lung surgery\n* Chronic shoulder problem\n* Epigastric pain\n* Lung disease such as emphysema or pneumothorax\n* Severe kidney or liver disease\n* Drug allergy (NSAIDs, Paracetamol)\n* On current medication: corticosteroid\n* Psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT04642118', 'briefTitle': 'Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '147/2563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary recruitment maneuver 30 cmH2O', 'description': 'After laparoscopic surgery has finished in operator room (before moving off trocar), patient will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.\n\nThe patients in this group will be received positive pressure from Pulmonary recruiment maneuver \\[balloon bag\\] from anesthesiologist 5 times of setting pressure 30 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas', 'interventionNames': ['Procedure: Pulmonary recruitment maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulmonary recruitment maneuver 40 cmH2O', 'description': 'After laparoscopic surgery has finished in operator room (before moving off trocar), patient will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.\n\nThe patients in this group will be received positive pressure from Pulmonary recruiment maneuver \\[balloon bag\\] from anesthesiologist 5 times of setting pressure 40 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas', 'interventionNames': ['Procedure: Pulmonary recruitment maneuver']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'After laparoscopic surgery has finished in operator room (before moving off trocar), patient will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.\n\nThe patients in this group will not be received any positive pressure from Pulmonary recruiment maneuver \\[balloon bag\\] from anesthesiologist.'}], 'interventions': [{'name': 'Pulmonary recruitment maneuver', 'type': 'PROCEDURE', 'description': 'Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time', 'armGroupLabels': ['Pulmonary recruitment maneuver 30 cmH2O', 'Pulmonary recruitment maneuver 40 cmH2O']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Anon Yodruangwong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Resident'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}