Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT07187427
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}, {'id': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly divided into two groups. The first group will receive an intrathecal injection of fentanyl, while the second will receive epidural fentanyl.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pruritus', 'timeFrame': 'Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia', 'description': 'Incidence et severity\n\n* 4-point Likert scale: Absent, light, moderate, severe/unbearable.\n* number of patients treated by antipruritic (Naloxone)'}], 'secondaryOutcomes': [{'measure': 'Nausea Vomiting', 'timeFrame': '2 hours until neuraxial analgesia', 'description': 'Incidence : Present or not Severity : number of patients treated (antinausea)'}, {'measure': 'Hypotension', 'timeFrame': '2 hours until neuraxial analgesia', 'description': 'Incidence : Decrease of arterial systolic pressure \\< 20% from basal Severity : Total dose of IV ephedrine'}, {'measure': 'Urinary rentention', 'timeFrame': '24 hours until the neuraxial analgesia', 'description': 'Number of urinary catheterizations'}, {'measure': 'Maternal satisfaction', 'timeFrame': '24 hours until neuraxial analgesia', 'description': 'Maternal satisfaction with neuraxial analgesia using :\n\n* Quality of Recovery-15 scale (QoR 15) : Score of 150 points to evaluate the recovery. The higher the score, the better the recovery.\n* Overall Benefit of Analgesia Score (OBAS) : multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events, and patient satisfaction. Score of 28. The lowest the score, the better the benefits.'}, {'measure': 'Fetal Bradycardia', 'timeFrame': '2 hours until neuraxial analgesia', 'description': "Incidence of fetal bradycardia Fetal monitoring is performed before and after the procedure. If a non-reassuring tracing is described by the obstetrical team, it will be noted in the patient's file. Fetal rhythm abnormalities via cardiotocogram are defined by nurses or obstetricians."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuraxial opioid induced pruritus during labor', 'Intrathecal fentanyl versus Epidural fentanyl'], 'conditions': ['Pruritis', 'Hypotension Drug-Induced', 'Urinary Retention', 'Fetal Bradycardia During Labor', 'Nausea and Vomitting', 'Satisfaction, Patient', 'Labor Analgesia', 'Neuraxial Opioid', 'Opioid Analgesic Adverse Reaction', 'Term Labour', 'Fentanyl Analgesia', 'Fentanyl Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '31704251', 'type': 'BACKGROUND', 'citation': 'Grangier L, Martinez de Tejada B, Savoldelli GL, Irion O, Haller G. Adverse side effects and route of administration of opioids in combined spinal-epidural analgesia for labour: a meta-analysis of randomised trials. Int J Obstet Anesth. 2020 Feb;41:83-103. doi: 10.1016/j.ijoa.2019.09.004. Epub 2019 Sep 23.'}, {'pmid': '24106351', 'type': 'BACKGROUND', 'citation': 'Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.'}, {'pmid': '15321435', 'type': 'BACKGROUND', 'citation': 'Wong CA, Scavone BM, Slavenas JP, Vidovich MI, Peaceman AM, Ganchiff JN, Strauss-Hoder T, McCarthy RJ. Efficacy and side effect profile of varying doses of intrathecal fentanyl added to bupivacaine for labor analgesia. Int J Obstet Anesth. 2004 Jan;13(1):19-24. doi: 10.1016/S0959-289X(03)00106-7.'}, {'pmid': '11012498', 'type': 'BACKGROUND', 'citation': 'Shah MK, Sia AT, Chong JL. The effect of the addition of ropivacaine or bupivacaine upon pruritus induced by intrathecal fentanyl in labour. Anaesthesia. 2000 Oct;55(10):1008-13. doi: 10.1046/j.1365-2044.2000.01618-2.x.'}, {'pmid': '9477056', 'type': 'BACKGROUND', 'citation': 'Palmer CM, Cork RC, Hays R, Van Maren G, Alves D. The dose-response relation of intrathecal fentanyl for labor analgesia. Anesthesiology. 1998 Feb;88(2):355-61. doi: 10.1097/00000542-199802000-00014.'}, {'pmid': '28067707', 'type': 'BACKGROUND', 'citation': 'Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women. Specifically, this study aim to compare intrathecal fentanyl with epidural fentanyl in order to determine whether the epidural route is associated with a lower occurrence and severity of pruritus. By clarifying these differences, the research seek to optimize analgesic strategies during labor while minimizing opioid-related side effects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Vaginal delivery\n* Gestational age ≥ 37 weeks\n* Requesting neuraxial analgesia\n* French or English language\n\nExclusion Criteria:\n\n* ASA score \\> 3\n* Allergy or contraindication to receiving opioids/local anesthesia (morphine or fentanyl)\n* BMI \\> 40 kg/m²\n* Hepatic or renal failure,\n* Severe preeclampsia and signs of severity according to the criteria of the American College of Obstetricians and Gynecologists\n* Maternal hemorrhage (placental abruption, hepatic subcapsular hematoma,...)\n* Severe scoliosis\n* Biliary cholestasis or polymorphic eruption of pregnancy\n* Inability to provide informed consent, either secondary to mental or physical disability or a significant language barrier (inability to understand English or French)\n* Prior administration of an opioid or opioid misuse'}, 'identificationModule': {'nctId': 'NCT07187427', 'briefTitle': 'Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.', 'orgStudyIdInfo': {'id': '2026-9304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal', 'description': 'Intrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%', 'interventionNames': ['Procedure: Spinal analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural', 'description': 'Epidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg', 'interventionNames': ['Procedure: Epidural Analgesia']}], 'interventions': [{'name': 'Spinal analgesia', 'type': 'PROCEDURE', 'otherNames': ['Spinal', 'fentanyl'], 'description': 'All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.\n\nSTEP 1: Intraspinal SPINAL Group: Bupivacaine 0.25% Isobaric 1 ml + Fentanyl 15 mcg, (0,3ml)\n\nSTEP 2: Epidural SPINAL group: 0.9% NaCl 2 ml.', 'armGroupLabels': ['Spinal']}, {'name': 'Epidural Analgesia', 'type': 'PROCEDURE', 'otherNames': ['Epidural', 'fentanyl'], 'description': 'All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter.\n\nSTEP 1: Intraspinal EPI Group: Bupivacaine 0.25% Isobaric 1 ml + NaCl 0.9% 0.3 ml\n\nSTEP 2: Epidural EPI group: Fentanyl 100 mcg, (2 ml of a concentration of 50 mcg/ml)', 'armGroupLabels': ['Epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Valérie Zaphiratos, MD, MSc, FRCPC Anesthesiology', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology', 'role': 'CONTACT', 'email': 'valerie@zaphiratos.ca', 'phone': '5146684778'}, {'name': 'Aymen Messadaa, MD, Anesthesiology', 'role': 'CONTACT', 'email': 'aymen.messadaa@umontreal.ca', 'phone': '514-603-5177'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Valerie Zaphiratos', 'investigatorAffiliation': "St. Justine's Hospital"}}}}