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

Z

Zagazig University

Status

Completed

Conditions

Analgesia

Treatments

Drug: caffeine, paracetamol tablet
Drug: oral pregabalin
Drug: Oral prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT04662125
6324

Details and patient eligibility

About

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.

Full description

To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups. To detect any side effects of the study medications in all patient groups.

Enrollment

63 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • - Both gender.
  • Age: 18- 65 years old.
  • Body Mass Index 20-30 kg/m2
  • American Society of Anesthesiologist (ASA) physical status I - II.
  • Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .

Exclusion criteria

  • - Allergy to study drugs.
  • History of chronic headache and migraine.
  • History of cerebrovascular accidents and neurological disorders.
  • Systemic infection
  • History of uncontrolled DM or hepatic disease or pregnant female
  • Patient refusal or uncooperative patient.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

63 participants in 3 patient groups

group A
Active Comparator group
Description:
Group A (conservative treatment): 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.
Treatment:
Drug: caffeine, paracetamol tablet
group B
Active Comparator group
Description:
Group B (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.
Treatment:
Drug: Oral prednisolone
group C
Active Comparator group
Description:
Group C (oral pregabalin): patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.
Treatment:
Drug: oral pregabalin

Trial contacts and locations

1

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Central trial contact

Dina Salem, MD

Data sourced from clinicaltrials.gov

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