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Clinical Trials/CTRI/2023/05/052352
CTRI/2023/05/052352Not yet recruitingPhase 3 4

Incidence of postdural puncture headache and low backache following median versus paramedian approach under spinal anaesthesia in elective caesarean section: A randomized double blind trial.

DR. SHREYA DUTTA1 site in 1 country166 target enrollmentStarted: May 15, 2023Last updated:
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Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
166
Locations
1
Primary Endpoint
Incidence of PDPH in two different approaches of subarachnoid block
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Paramedian approach can be considered as a superior alternative to median approach under spinal anaesthesia in reducing post dural puncture headache and low backache in routine practice by overcoming the disadvantaged of paramedian approach thereby decreasing the postoperative ambulation time.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •1.Patients posted for elective caesarean section under spinal anaesthesia 2.American Society of Anaesthesiologists (ASA) physical status-II III 3.Age 18-40 years.

Exclusion Criteria

  • •1.Any contraindication to spinal anaesthesia.
  • •Any chronic preoperative headache, cluster headache, stress headache
  • •Patient with chronic backache.
  • •4.History of Pelvic inflammatory disease.
  • •5.Lumbar puncture attempt greater than three 6.BMI>35.

Outcomes

Primary Outcomes

Incidence of PDPH in two different approaches of subarachnoid block

Time Frame: 24hr,72 hr 7 days

Secondary Outcomes

  • 1.The severity of headache at 24hrs,72hrs and after a week using VAS score

Investigators

Sponsor
DR. SHREYA DUTTA
Sponsor Class
Other [SELF FUNDED]

Study Sites (1)

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