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NCT Number: NCT04662125

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

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.

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Key information

Conditions

Analgesia Agnosia Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-Dural Puncture Headache Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Zagazig university

Zagazig, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

caffeine, paracetamol tablet

Drug

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.

Oral prednisolone

Drug

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. .

oral pregabalin

Drug

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

Primary outcomes

  1. pain intensity of headache

    Time frame: From onset of the headache (0 hour).

    measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

  2. pain intensity of headache

    Time frame: at 12 hours

    measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

  3. pain intensity of headache

    Time frame: at 24 hours

    measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

  4. pain intensity of headache

    Time frame: at 48 hours

    measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

  5. pain intensity of headache

    Time frame: at 72 hours

    measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

  6. Headache intensity

    Time frame: From onset of the headache (0 hour).

    modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.

  7. Headache intensity

    Time frame: at 12 hours

    modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.

  8. Headache intensity

    Time frame: at 24 hours

    modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.

  9. Headache intensity

    Time frame: at 48 hours

    modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.

  10. Headache intensity

    Time frame: at 72 hours

    modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.

Secondary outcomes

  1. Associated symptoms of post dural puncture headache

    Time frame: for 72 hours

    The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness

  2. Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness

    Time frame: for 72 hours

    In case of sedation, the level will be assessed by using Ramsay Sedation Score (1= anxious or agitated, 2= cooperative and oriented, 3= responds to commands only and 4= brisk response to light tap or loud auditory stimulus)

  3. total dose of rescue analgesia

    Time frame: for 72 hours

    total amount of ketorolac

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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