Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05746351
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Additives to Epidural Bupivacaine in Normal Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D009266', 'term': 'Nalbuphine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score for pain', 'timeFrame': 'before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.', 'description': 'changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epidural anathesia', 'normal labor'], 'conditions': ['Labor Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32333825/', 'label': 'Paramasivan A, Lopez-Olivo MA, Foong TW, et al. Intrathecal dexmedetomidine and postoperative pain: a systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020;24(7):1215-1227'}, {'url': 'https://innovareacademics.in/journals/index.php/ajpcr/article/view/26096', 'label': 'Senapati LK, Samanta P. Effect of intravenous versus intrathecal dexmedetomidine on characteristics of hyperbaric bupivacaine spinal anesthesia in lower limb surgery. Asian J Pharm Clin Res. 2018;11:427-430.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27746540/', 'label': 'Santpur MU, Kahalekar GM, Saraf N, et al. Effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: a prospective randomized control study. Anesth Essays Res. 2016;10(3):497-501.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6493572/', 'label': '\\] Niu XY, Ding XB, Guo T, et al. Effects of intravenous and intrathecal dexmedetomidine in spinal anesthesia: a meta-analysis. CNS Neurosci Ther. 2013;19(11):897-904.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/1914055/', 'label': 'Camann WR, Hurley RH, Gilbertson LI, et al. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991;38(6):728-732.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/26712968/', 'label': '\\] Chatrath V, Attri JP, Bala A, et al. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015;9(3):326.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.', 'detailedDescription': 'Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased .\n\nRecently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction .\n\nEpidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia .\n\nStudies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics.\n\nDexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .\n\nIt has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension .\n\nNalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses .\n\nThe analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 18 years of age\n* American Society of Anesthesiologists (ASA) Physical Status 2 or 3\n* Full term pregnancy (\\>37 gestational weeks)\n* Planning vaginal delivery\n* Planning epidural labor analgesia\n* Vertex presentation\n\nExclusion Criteria:\n\n* Patient refusal to epidural analgesia,\n* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)\n* Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)\n* hemodynamic instability, severe aortic or mitral stenosis)\n* Severe pre-eclampsia,\n* Breech presentations\n* Antepartum hemorrhage\n* Cephalopelvic disproportion\n* Body mass index ≥40 kg/m2.\n* Uncontrolled systemic comorbidities \\[i.e., diabetes, hepatic, renal or cardiac\\]\n* Known or suspected fetal abnormalities\n* Inability to communicate or participate in study procedures'}, 'identificationModule': {'nctId': 'NCT05746351', 'briefTitle': 'Analgesic Additives to Epidural Bupivacaine in Normal Labor', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.', 'orgStudyIdInfo': {'id': 'epidural additives in labor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'epidural Bupivacaine with Dexmedetomidine in normal labor', 'description': 'Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epidural Bupivacaine with fentanyl in normal labor', 'description': 'Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.', 'interventionNames': ['Drug: fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epidural Bupivacaine with Nalbuphine in normal labor', 'description': 'Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.', 'interventionNames': ['Drug: Nalbuphine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor', 'armGroupLabels': ['epidural Bupivacaine with Dexmedetomidine in normal labor']}, {'name': 'fentanyl', 'type': 'DRUG', 'otherNames': ['Durogesic'], 'description': 'a group will receive epidural Bupivacaine with fentanyl in normal labor', 'armGroupLabels': ['epidural Bupivacaine with fentanyl in normal labor']}, {'name': 'Nalbuphine', 'type': 'DRUG', 'otherNames': ['Nalufin'], 'description': 'a group will receive epidural Bupivacaine with Nalbuphine in normal labor', 'armGroupLabels': ['epidural Bupivacaine with Nalbuphine in normal labor']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abanob Fathy Zareef, MBBS', 'role': 'CONTACT', 'email': 'bebofathy47@gmail.com', 'phone': '01010424707'}], 'overallOfficials': [{'name': 'Zein EA Zareh Hassan, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Elwani Eldramy Elsenosi, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Khaled Tolba Younes, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Abanob Fathy Zareef', 'investigatorAffiliation': 'Assiut University'}}}}