Post-Dural Puncture HeadacheNCT07436403
Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach
A study testing Spinal anesthesia using median approach (midline) and Spinal anesthesia using paramedian approach in people with Post-Dural Puncture Headache and Headache After Spinal Puncture, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Dural Puncture Headache, Headache After Spinal Puncture
- What is being tested?
- Spinal anesthesia using median approach (midline) and Spinal anesthesia using paramedian approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePakistan
- Study dates
- May 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Mayo Hospital, Lahore
Lahore, Punjab Province, 54000
Ali Raza Ihsan, +923311491996, aliraza45901@gmail.com
About this study
Official title: Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach: A Randomized Controlled Trial
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.
- Being tested
- Spinal anesthesia using median approach (midline), Spinal anesthesia using paramedian approach
- Keywords
- Post-dural puncture headache, Spinal anesthesia, Median approach, Paramedian approach, Randomized controlled trial
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia using median approach (midline)Procedure or surgery
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 approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Median Approach) | Experimental | 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. Receives: Procedure: Spinal anesthesia using median approach (midline) |
| Group B (Paramedian Approach) | Active comparator | 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. Receives: Procedure: Spinal anesthesia using paramedian approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours, 72 hours, and day 5 after spinal anesthesia
Secondary outcomes (1)
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).
Measured: 24 hours, 72 hours, and day 5 after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Ali Raza Ihsan, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436403
- Sponsor's protocol ID
- Mayo2
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Dural Puncture Headache After Spinal Anesthesia Using Median Versus Paramedian Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07436403
- Acronym / sponsor ID
- Mayo2
- Keywords
- Post-dural puncture headache, Spinal anesthesia, Median approach, Paramedian approach, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Median Approach) | Experimental | Procedure: Spinal anesthesia using median approach (midline)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. |
| Group B (Paramedian Approach) | Active comparator | Procedure: Spinal anesthesia using paramedian approachParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Group A (Median Approach) |
| Spinal anesthesia using paramedian approachSpinal 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. | Procedure or surgery | Group B (Paramedian Approach) |
Primary outcome
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.
1 secondary outcome
Severity of post-dural puncture headache
Time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Raza Ihsan principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia using median approach (midline) and Spinal anesthesia using paramedian approach in people with Post-Dural Puncture Headache and Headache After Spinal Puncture, run by Mayo Hospital Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Raza Ihsan Ihsan (+923311491996, aliraza45901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-dural puncture headache (time frame: 24 hours, 72 hours, and day 5 after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.