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NCT Number: NCT07436403

Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender (male and female) aged between 18 and 65.
  • Adults undergoing elective orthopedics or urology procedures planned under spinal anesthesia.
  • ASA status I or II.
  • Ability to give informed consent and comply with postoperative assessment.

Exclusion criteria

  • 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.
  • Known hypersensitivity to planned intrathecal local anesthetic or adjuvant drugs.
  • History of chronic daily headache, migraine requiring regular prophylaxis, or headache at baseline on the day of surgery.
  • Prior lumbar spine surgery, significant spinal deformity, or neurological disease affecting lower limb sensation that will interfere with neuraxial assessment.
  • Inability to complete follow-up assessments due to impaired cognition, severe psychiatric illness, or major communication barrier.
  • Emergency procedures.

Treatment and study plan

Spinal anesthesia using median approach (midline)

Procedure

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 using paramedian approach

Procedure

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.

Primary outcomes

  1. Incidence of post-dural puncture headache

    Time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia

    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.

Secondary outcomes

  1. Severity of post-dural puncture headache

    Time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Raza Ihsan Ihsan

CONTACT

[email protected]

+923311491996

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Official study title

Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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