An interventional study of Spinal anesthesia using median approach (midline) and Spinal anesthesia using paramedian approach in Post-Dural Puncture Headache and Headache After Spinal Puncture, sponsored by Mayo Hospital Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Mayo Hospital Lahore · Not applicable, Interventional, and Prevention
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.
Eligible 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.
The 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.
Exclusion Criteria:
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.
Procedure: Spinal anesthesia using median approach (midline)
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.
Procedure: Spinal anesthesia using paramedian approach
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.
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.
Incidence of post-dural puncture headache
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.
Time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia
Severity of post-dural puncture headache
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).
Time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Mayo Hospital Lahore