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A clinical trial to study factors that affect occurrence of headache and backache in women after caesarean operation

Comparative evaluation of factors affecting post dural puncture headache and backache using two different techniques of spinal needle removal following spinal anaesthesia for caesarean delivery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010828
Enrollment
870
Registered
2017-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O294- Spinal and epidural anesthesia induced headache during pregnancy

Interventions

Intervention1: Stylet reinsertion: Reinsertion of stylet after a spinal anaesthesia procedure, prior to spinal needle removal Control Intervention1: No stylet reinsertion: Removal of spinal needle wit

Sponsors

Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists physical status I and II pregnant women 2. Aged 18 to 44 years 3. Undergoing elective or emergency Caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Severe pregnancy induced hypertension and eclampsia 3. Haemodynamic instability 4. Raised intracranial pressure 5. History of chronic headache episodes of unknown cause 6. Chronic use of analgesics 7. Spinal deformity or previous spine surgery 8. Patients with bleeding diathesis or coagulopathy 9. Infection at the site of spinal injection 10. Patients with contraindications to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To determine the effect of reinsertion of the stylet after a spinal anaesthesia procedure, prior to spinal needle removal, on the incidence, onset, severity and duration of post dural puncture headacheTimepoint: At 12h, 24h, 36h, 48h, 60h 72h, Day 5 and Day 7—

Secondary

MeasureTime frame
1. To determine the incidence of post dural puncture backache (PDPB) 2. To determine the risk factors associated with PDPH and PDPB in women undergoing Caesarean delivery. Timepoint: At 12h, 24h, 36h, 48h, 60h 72h, Day 5 and Day 7—

Countries

India

Contacts

Public ContactSmita Prakash

Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi

drsunilprakash@gmail.com9810347125

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026