Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-05 @ 2:59 AM
Study NCT ID:
NCT06716359
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-13
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Regression analysis of inadequate analgesia', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Univariate and multivariate regression analysis of inadequate postoperative analgesia. Postoperative pain is represented by NRS score (0-10). The higher the NRS score, the more severe the pain. A NRS score of ≥ 4 is considered inadequate analgesia.'}, {'measure': 'Acute postoperative pain predictive model', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Development and validation of a predictive model for acute postoperative pain after cesarean section.'}], 'primaryOutcomes': [{'measure': 'Incidence of pain after caesarean section', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain'}, {'measure': 'Incidence of inadequate analgesia', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Postoperative pain is represented by NRS score (0-10). The higher the NRS score, the more severe the pain. A NRS score of ≥ 4 is considered inadequate analgesia.'}], 'secondaryOutcomes': [{'measure': 'Adverse effects of postoperative analgesia', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Incidence and the risk factors of adverse effects of postoperative analgesia'}, {'measure': 'Usage of patient controlled analgesia (PCA)', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Assessment of PCA Press Count and PCA Consumption'}, {'measure': 'Diclofenac sodium dosage', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Diclofenac sodium dosage after caesarean section'}, {'measure': 'Patient satisfaction', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Assessment of patient satisfaction by score from 0 to ten, The higher the score, the more satisfied the patient.'}, {'measure': 'Length of hospital stay', 'timeFrame': '2024-12-05-2025-05-30', 'description': 'Assessment of the length of hospital stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'Cesarean section surgery', 'Hydromorphone', 'Nalbuphine', 'Predictive Model', 'patiet controlled analgesia'], 'conditions': ['Postoperative Pain', 'Patiet Controlled Analgesia']}, 'referencesModule': {'references': [{'pmid': '31145215', 'type': 'BACKGROUND', 'citation': 'Sharpe EE, Booth JL, Houle TT, Pan PH, Harris LC, Aschenbrenner CA, Eisenach JC. Recovery of physical activity after cesarean delivery and its relationship with pain. Pain. 2019 Oct;160(10):2350-2357. doi: 10.1097/j.pain.0000000000001628.'}, {'pmid': '34559941', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Betran AP, Li X, Liu D, Yuan N, Shang L, Lin W, Tu S, Wang L, Wu X, Zhu T, Zhang Y, Lu Z, Zheng L, Gu C, Fang J, Liu Z, Ma L, Cai Z, Yang X, Li H, Zhang H, Zhao X, Yan L, Wang L, Sun X, Luo Q, Liu L, Zhu J, Qin W, Yao Q, Dong S, Yang Y, Cui Z, He Y, Feng X, He L, Zhang H, Zhang L, Wang X, Souza JP, Qi H, Duan T, Zhang J. What is an appropriate caesarean delivery rate for China: a multicentre survey. BJOG. 2022 Jan;129(1):138-147. doi: 10.1111/1471-0528.16951. Epub 2021 Oct 26.'}, {'pmid': '28030701', 'type': 'BACKGROUND', 'citation': 'Li HT, Luo S, Trasande L, Hellerstein S, Kang C, Li JX, Zhang Y, Liu JM, Blustein J. Geographic Variations and Temporal Trends in Cesarean Delivery Rates in China, 2008-2014. JAMA. 2017 Jan 3;317(1):69-76. doi: 10.1001/jama.2016.18663.'}, {'pmid': '20071021', 'type': 'BACKGROUND', 'citation': 'Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, Attygalle DE, Shrestha N, Mori R, Nguyen DH, Hoang TB, Rathavy T, Chuyun K, Cheang K, Festin M, Udomprasertgul V, Germar MJ, Yanqiu G, Roy M, Carroli G, Ba-Thike K, Filatova E, Villar J; World Health Organization Global Survey on Maternal and Perinatal Health Research Group. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010 Feb 6;375(9713):490-9. doi: 10.1016/S0140-6736(09)61870-5. Epub 2010 Jan 11.'}, {'pmid': '19819416', 'type': 'BACKGROUND', 'citation': 'Klemetti R, Che X, Gao Y, Raven J, Wu Z, Tang S, Hemminki E. Cesarean section delivery among primiparous women in rural China: an emerging epidemic. Am J Obstet Gynecol. 2010 Jan;202(1):65.e1-6. doi: 10.1016/j.ajog.2009.08.032. Epub 2009 Oct 12.'}]}, 'descriptionModule': {'briefSummary': "Cesarean section is an essential surgical procedure in obstetrics, which not only addresses dystocia and certain obstetric syndromes, ensuring the safety of the maternal participants, but also increases perinatal survival rates and can save the mother's life. However, the surgical trauma and uterine contractions resulting from cesarean delivery lead to severe pain, which can hinder the mother's postoperative recovery and negatively affect her mental health. Therefore, improving postoperative pain management and addressing issues such as depression and anxiety are crucial challenges in clinical practice today.\n\nPatient-controlled intravenous analgesia (PCA) is widely used in postoperative pain management after cesarean section due to its ability to maintain the minimum effective drug concentration, minimal fluctuation in drug levels, ease of management, and no restriction on activity. However, research on the effects and adverse reactions of hydromorphone and nalbuphine for postoperative pain relief in cesarean section is limited.\n\nIn this study, the investigators aim to compare the effects of hydromorphone hydrochloride and nalbuphine in obstetric PCA and examine how various clinical factors influence pain outcomes and adverse reactions. Based on multivariate analysis, the investigators further aim to construct and validate a predictive model for poor analgesic outcomes. To develop more personalized strategies for postoperative pain management following cesarean section, more personalized guidance strategies for postoperative pain management following cesarean section."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women planning to undergo cesarean section surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 20 to 50 years old;\n* ASA grades I to III;\n* Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;\n* Pregnant women who are willing to participate in this study and sign informed consent forms.\n\nExclusion Criteria:\n\n* Have a history of dementia, mental illness, or any central nervous system disorder;\n* Pregnant women who are addicted to alcohol and drugs;\n* Difficulty in follow-up or poor patient compliance;\n* Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;\n* Serious complications occur during delivery;\n* Unable to cooperate with the research for any reason.'}, 'identificationModule': {'nctId': 'NCT06716359', 'briefTitle': 'Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section', 'orgStudyIdInfo': {'id': 'Acute postoperative pain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cesarean section surgery', 'description': 'Observational study', 'interventionNames': ['Other: Observational study without intervention']}], 'interventions': [{'name': 'Observational study without intervention', 'type': 'OTHER', 'description': 'Observational study without intervention', 'armGroupLabels': ['Cesarean section surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xianwei Zhang，MD', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}