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Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

NCT04662125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-11-01

No results posted yet for this study

Summary

The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.

Conditions

  • Analgesia

Interventions

DRUG

caffeine, paracetamol tablet

oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days.

DRUG

Oral prednisolone

patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. .

DRUG

oral pregabalin

patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Dina Salem, MD · faculty of medicine , Zagazig university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662125 on ClinicalTrials.gov