Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2026-01-20 @ 4:49 PM
Study NCT ID:
NCT06607861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity', 'timeFrame': 'at enrollment,1,3,6, 12, 24,36, 48, 72 hours', 'description': 'Visual analogue scale from 0 to ten . 0 = no pain. 1-3=mild pain, 4-6= moderate. 7- 10= severe un imaginable pain'}], 'secondaryOutcomes': [{'measure': 'leybecker classification', 'timeFrame': 'At enrollment, 1,3,6, 12,24,36,48, 73 hours', 'description': 'degree of headache ... \\<2 = mild pain.. \\> 2= severe pain'}, {'measure': 'Transcranial doppler', 'timeFrame': 'at enrollment, 24,48,72 hours', 'description': 'Measuring mean flow velocity'}, {'measure': 'NEED for epidural blood patch', 'timeFrame': '72 hours during the invesigation', 'description': 'Visual analogue scale from 0 to ten . 0 = no pain. 1-3=mild pain, 4-6= moderate. 7- 10= severe un imaginable pain. Epidural blood patch if visual analogue scale more than or equal 4.'}, {'measure': 'Procedural related complications', 'timeFrame': '72 hours from the procedure', 'description': 'hypotension, bradycardia'}, {'measure': 'persistent symptoms', 'timeFrame': 'one week after hospital discharge', 'description': 'Tinnitus, photophobia, orthostatic hypotension'}, {'measure': 'transcranial doppler', 'timeFrame': 'at enrollment, 24,48,72 hours', 'description': 'pulsatality index'}, {'measure': 'transcranial doppler', 'timeFrame': 'at enrollment, 24,48,72 hours', 'description': 'resisitive index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Score (VAS)']}, 'descriptionModule': {'briefSummary': 'Post-dural puncture headache (PDPH) is a well-recognized and potentially serious complication of subarachnoid block. While advancements in spinal needle design have reduced its incidence in recent years, PDPH still affects a notable percentage of post-partum patients undergoing spinal anaesthesia, with rates ranging from 0.5% to 2%. Factors such as female gender, pregnancy, young age, low body mass index, dilutional anemia, and the preference for neuraxial anaesthesia during caesarean section (CS) increase the vulnerability of obstetric patients to PDPH. Therefore, managing this complication is critically important in obstetric anaesthesia.\n\nThe exact cause of PDPH remains unclear, but there is substantial evidence suggesting that it stems from reduced cerebrospinal fluid (CSF) pressure due to continuous leakage through a dural tear, which exceeds the rate of CSF production. This imbalance can lead to PDPH, as even a modest loss of CSF volume (as little as 10%) can trigger traction on pain-sensitive intracranial structures when in an upright position, compounded by reflexive vasodilation.\n\nVarious treatment strategies have been proposed, typically including bed rest in a supine position, fluid therapy, analgesics, and medications such as sumatriptan and caffeine.\n\nDexmedetomidine (DEX) is a highly specific agonist of α2-adrenoreceptors known for inducing cooperative sedation, anxiolysis, and analgesia while minimizing respiratory depression. Additionally, it has been shown to mitigate the stress and inflammatory response triggered by surgical and anaesthetic procedures. Activation of α2-receptors in the substantia gelatinosa of the dorsal horn suppresses the firing of nociceptive neurons and inhibits the release of substance P. Furthermore, stimulation of these receptors in the locus coeruleus, a key modulator of nociceptive transmission, interrupts the transmission of pain signals, resulting in analgesia. Dexmedetomidine has been administered via intranasal and inhalational routes for various purposes, including premedication, sedation, and post-operative analgesia.\n\nLidocaine nebulized is a novel method used recently for PDPH. Intranasal lidocaine can offer sphenopalatine ganglion block which can facilitate acute pain reduction in PDPH.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \\[14\\] and Lybecker classification score ≥ 2\n\nExclusion Criteria:\n\n* Emergency caesarean section.\n* Pregnancy induced hypertension\n* Contraindications for sub-arachinoid block ( coagulopathy, infection )\n* History of chronic headache, migraine, trigeminal neuralgia\n* Refusal to participate\n* History of cerebrovascular stroke\n* BMI\\> 35\n* History of obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT06607861', 'briefTitle': 'Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: A Randomized Bicentric Study', 'orgStudyIdInfo': {'id': 'R/603- Anet19-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'nebulization of 4 mL 0.9% saline plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management', 'interventionNames': ['Drug: saline group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dex. group', 'description': 'nebulization of 1 µg/kg dexmedetomidine diluted in 4 mL 0.9% saline twice daily ( fixed times 9 a.m, and 9 p.m) plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management', 'interventionNames': ['Drug: dexmedetomidine group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine group', 'description': 'bilateral nebulization (60 mg) using a mucosal atomization device twice daily plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management', 'interventionNames': ['Drug: lidocaine group']}], 'interventions': [{'name': 'saline group', 'type': 'DRUG', 'otherNames': ['nebulization of 4 mL 0.9% saline twice daily'], 'description': 'nebulization of 4 mL 0.9% saline twice daily', 'armGroupLabels': ['Control group']}, {'name': 'dexmedetomidine group', 'type': 'DRUG', 'description': 'nebulization of 1 µg/kg dexmedetomidine diluted in 4 mL 0.9% saline twice daily', 'armGroupLabels': ['Dex. group']}, {'name': 'lidocaine group', 'type': 'DRUG', 'description': 'bilateral nebulization (60 mg) using a mucosal atomization device twice daily', 'armGroupLabels': ['Lidocaine group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass professor anesthesia and pain', 'investigatorFullName': 'Mina Maher', 'investigatorAffiliation': 'Minia University'}}}}