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

Summary

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.

Conditions

• Post-Dural Puncture Headache
• Headache After Spinal Puncture

Interventions

PROCEDURE

Spinal anesthesia using median approach (midline)

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.

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), 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.

Sponsors & Collaborators

• Mayo Hospital Lahore

  lead OTHER

Principal Investigators

• Ali Raza Ihsan · Mayo Hospital Lahore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• Pakistan

Study Locations