A randomized prospective comparative study of incidence of post dural pucture backache(PDPB) following median and paramedian approach for administration of subarachnoid block in patients undergoing cesarian section

A randomized prospective comparative study of incidence of post dural pucture backache(PDPB) following median and paramedian approach for administration of subarachnoid block in patients undergoing cesarian section - Nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/05/066701

Enrollment

210

Registered

2024-05-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: O745- Spinal and epidural anesthesia-induced headache during labor and delivery

Interventions

Intervention1: Paramedian approach for spinal Anaesthetseia: In this approach the spinal needle is inserted 1 cm lateral and 1 cm caudal to the caudal edge of the most superior spinous process in the

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing elective / emergency cesarean section ASA grades |-|||

Exclusion criteria

Exclusion criteria: Patients refusing to participate in the study History of allergy to local anesthetics Patients with coagulopathy or infection at the site of block Patients with psychiatric illness or cognitive dysfunction Patients with the history of previous back surgery, spondylolisthesis, and other lumbar disorders Previous history of low back pain Failure of spinal anesthesia

Design outcomes

Primary

Measure	Time frame
To determine the incidence of post-dural puncture backache (PDPB) in both groups in the first 3 months postoperativelyTimepoint: 3 months postoperatively	—

Secondary

Measure	Time frame
Backache on Numerical Rating Scale (NRS) in both groups after 24 hours,1 week, 1 month, 2 months and 3 months postoperatively The number of attempts required at subarachnoid block by either approach Total requirement of additional analgesics for low backache in first 24 and 48 hours postoperatively (Morphine equivalents) Compare the incidence of PDPH in the two groups in first 72 hours Timepoint: 24 and 48 hours, 72 hours	—

Measure

Time frame

Backache on Numerical Rating Scale (NRS) in both groups after 24 hours,1 week, 1 month, 2 months and 3 months postoperatively The number of attempts required at subarachnoid block by either approach Total requirement of additional analgesics for low backache in first 24 and 48 hours postoperatively (Morphine equivalents) Compare the incidence of PDPH in the two groups in first 72 hours Timepoint: 24 and 48 hours, 72 hours

—

Countries

India

Contacts

Public ContactDr Sulekha

Tata Main Hospital Jamshedpur Jharkhand

bhanu.swain@tatasteel.com9471519719

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026