Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05624502
Status:
UNKNOWN
Last Update Posted:
2022-12-27
First Post:
2022-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement in Postoperative Pain Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-22', 'studyFirstSubmitDate': '2022-11-13', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain scores', 'timeFrame': 'first 3 days postoperative', 'description': 'using visual analogue scale (VAS) for pain assessment of 11 points (from "0" no pain to "10" worst pain'}, {'measure': 'time in severe pain', 'timeFrame': 'during the first 24 hours', 'description': 'duration of time spent in severe pain after surgery'}, {'measure': 'dynamic and static pain', 'timeFrame': 'during the first 24 hours', 'description': 'Pain scores or rest and during movements'}], 'secondaryOutcomes': [{'measure': 'worst and least pain', 'timeFrame': 'during the first 24 hours', 'description': 'The highest and lowest pain scores during the first 24 hours'}, {'measure': 'time to first request of analgesia', 'timeFrame': 'during the first 24 hours', 'description': 'the time from the recovery to the first request of postoperative analgesia'}, {'measure': 'total analgesic consumption', 'timeFrame': 'during the first 24 hours', 'description': 'total consumption of opioids / non-opioids during the first 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute postoperative pain', 'orthopedic surgery', 'general surgery', 'obs/gyn surgery', 'Neurosurgery', 'Bariatric surgery', 'Thoracic surgery', 'opioids', 'NSAIDs', 'Regional analgesia'], 'conditions': ['Acute Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Then they will suggest recommendations to improve the current situation of postoperative pain management.', 'detailedDescription': 'At least half of the patients suffer from moderate to severe post-operative pain. The price of poorly managed pain is high: pain impedes recovery, causes suffering and prolongs the hospital stay. PAIN OUT provides tools for measurement, feedback and benchmarking of pain treatment quality in order to improve patient care. A research project that aims at improving postoperative pain treatment outcomes by evaluating the current status of postoperative pain managements in our institution. Then the investigators compare the results by internal and external benchmarking. Then suggest recommendations to improve the current situation of postoperative pain management.\n\nparameters include" Patient\'s data Pain assessments by using the visual analogue score of 11 point (from "0" no pain - "10" worst pain) will be evaluated as the following: Worst pain since surgery, Least pain since surgery, Pain score at rest. Pain score during movements in bed, Pain score during deep breathing and coughing, How often the severe pain since surgery (%), Does the pain interfere with sleeping pattern, and the side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute postoperative pain patients after different surgical procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postoperative patients during the first 24 hours of surgery (day 1)\n* Male and Females\n* Adults\n\nExclusion Criteria:\n\n* Patient refusal\n* Drug abusers and addicts\n* Major significant systemic diseases\n* Language barriers'}, 'identificationModule': {'nctId': 'NCT05624502', 'briefTitle': 'Improvement in Postoperative Pain Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Mprovement in Postoperative Pain Outcome: Pain Registry', 'orgStudyIdInfo': {'id': '18/0443/IRB'}}, 'contactsLocationsModule': {'locations': [{'zip': '7805', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'SALAH N. N. EL-TALLAWY', 'role': 'CONTACT', 'email': 'salaheltallawy@yahoo.com', 'phone': '0114692191'}], 'facility': 'Salah N. El-Tallawy', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Consultant - Anesthesia and Pain Management', 'investigatorFullName': 'SALAH EL-TALLAWY', 'investigatorAffiliation': 'King Saud University'}}}}