Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:22 AM
Study NCT ID:
NCT07436403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-dural puncture headache', 'timeFrame': '24 hours, 72 hours, and day 5 after spinal anesthesia', 'description': 'Proportion of participants developing post-dural puncture headache, defined as a headache occurring within 5 days after spinal anesthesia that worsens within 15 minutes of sitting or standing and improves within 15 minutes of lying down, with at least one associated feature (neck stiffness, tinnitus, hypoacusis, photophobia, or nausea). Diagnosis will be confirmed using a structured checklist based on International Headache Society International Classification of Headache Disorders, 3rd edition criteria.'}], 'secondaryOutcomes': [{'measure': 'Severity of post-dural puncture headache', 'timeFrame': '24 hours, 72 hours, and day 5 after spinal anesthesia', 'description': 'Headache intensity measured using a 10 cm Visual Analogue Scale (0 to 10), recorded at each scheduled assessment. Severity will be categorized as mild (1 to 3), moderate (4 to 6), or severe (7 to 10).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-dural puncture headache', 'Spinal anesthesia', 'Median approach', 'Paramedian approach', 'Randomized controlled trial'], 'conditions': ['Post-Dural Puncture Headache', 'Headache After Spinal Puncture']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will compare two commonly used techniques for performing spinal anesthesia, the median (midline) approach and the paramedian (lateral) approach, in adult patients undergoing elective orthopedic or urology surgery at Mayo Hospital, Lahore. Spinal anesthesia is widely used because it provides rapid pain control during surgery and avoids airway instrumentation. However, a recognized complication is post-dural puncture headache (PDPH), a headache that typically worsens on sitting or standing and improves on lying down. PDPH can delay mobilization, reduce oral intake, prolong hospital stay, and sometimes require additional treatment.\n\nEligible participants aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I or II will be enrolled, and then allocated in a 1:1 ratio to receive spinal anesthesia using either the median or paramedian approach. To standardize the procedure, spinal anesthesia will be performed under aseptic technique at the L3 to L4 or L4 to L5 interspace using a 25-gauge Quincke spinal needle, followed by injection of a fixed dose of hyperbaric bupivacaine. Routine perioperative monitoring will be applied for all participants, and intra-operative blood pressure will be recorded at regular intervals to document hypotension.\n\nThe primary outcomes are the frequency and severity of PDPH. PDPH will be assessed using a structured checklist based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) at 24 hours, 72 hours, and day 5 after the procedure by a trained assessor. Headache intensity will be recorded using a 0 to 10 Visual Analogue Scale, and categorized as mild, moderate, or severe. The hypothesis is that the frequency and severity of PDPH differ between the median and paramedian approaches in patients receiving spinal anesthesia for orthopedic or urology surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both gender (male and female) aged between 18 and 65.\n* Adults undergoing elective orthopedics or urology procedures planned under spinal anesthesia.\n* ASA status I or II.\n* Ability to give informed consent and comply with postoperative assessment.\n\nExclusion Criteria:\n\n* Any contraindication to spinal anesthesia, including infection at puncture site, coagulopathy or therapeutic anticoagulation, thrombocytopenia, severe hypovolemia or shock, raised intracranial pressure due to space occupying lesion, or suspected spinal canal infection.\n* Known hypersensitivity to planned intrathecal local anesthetic or adjuvant drugs.\n* History of chronic daily headache, migraine requiring regular prophylaxis, or headache at baseline on the day of surgery.\n* Prior lumbar spine surgery, significant spinal deformity, or neurological disease affecting lower limb sensation that will interfere with neuraxial assessment.\n* Inability to complete follow-up assessments due to impaired cognition, severe psychiatric illness, or major communication barrier.\n* Emergency procedures.'}, 'identificationModule': {'nctId': 'NCT07436403', 'briefTitle': 'Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Hospital Lahore'}, 'officialTitle': 'Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Mayo2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Median Approach)', 'description': 'Participants will receive spinal anesthesia using the median (midline) approach for elective orthopedic or urology surgery. The spinal needle will be introduced in the midline through the interspinous space until free cerebrospinal fluid flow is obtained, followed by intrathecal injection of a fixed dose of hyperbaric bupivacaine.', 'interventionNames': ['Procedure: Spinal anesthesia using median approach (midline)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Paramedian Approach)', 'description': 'Participants will receive spinal anesthesia using the paramedian approach for elective orthopedic or urology surgery. The needle entry point will be approximately 1 cm lateral and 1 cm caudal to the inferior border of the selected spinous process, directed medially and cephalad to access the subarachnoid space, followed by intrathecal injection of a fixed dose of hyperbaric bupivacaine.', 'interventionNames': ['Procedure: Spinal anesthesia using paramedian approach']}], 'interventions': [{'name': 'Spinal anesthesia using median approach (midline)', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed under aseptic technique at L3 to L4 or L4 to L5 using a 25-gauge Quincke spinal needle. After local infiltration with lignocaine 1% (2 mL), and confirmation of free cerebrospinal fluid flow, hyperbaric bupivacaine 0.75% (15 mg, 2 mL) will be injected intrathecally. Standard perioperative monitoring and postoperative care will be applied.', 'armGroupLabels': ['Group A (Median Approach)']}, {'name': 'Spinal anesthesia using paramedian approach', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed under aseptic technique at L3 to L4 or L4 to L5 using a 25-gauge Quincke spinal needle. After local infiltration with lignocaine 1% (2 mL), the needle will be inserted via the paramedian route (approximately 1 cm lateral and 1 cm caudal to the inferior border of the selected spinous process) and directed medially and cephalad. After confirmation of free cerebrospinal fluid flow, hyperbaric bupivacaine 0.75% (15 mg, 2 mL) will be injected intrathecally. Standard perioperative monitoring and postoperative care will be applied.', 'armGroupLabels': ['Group B (Paramedian Approach)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Ali Raza Ihsan', 'role': 'CONTACT', 'email': 'aliraza45901@gmail.com', 'phone': '+923311491996'}], 'facility': 'Mayo Hospital, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Ali Raza Ihsan Ihsan', 'role': 'CONTACT', 'email': 'aliraza45901@gmail.com', 'phone': '+923311491996'}], 'overallOfficials': [{'name': 'Ali Raza Ihsan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Hospital Lahore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Hospital Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adeel Ahmed', 'investigatorAffiliation': 'Mayo Hospital Lahore'}}}}