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

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04662125
Collaborator
(none)
63
1
3
7
9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral prednisolone
  • Drug: oral Pregabalin
  • Drug: caffeine, paracetamol tablet
N/A

Detailed Description

  1. To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.

  2. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.

  3. To detect any side effects of the study medications in all patient groups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalinAnalgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
anesthetist not sharing in the study will assess patient
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Dec 10, 2020
Anticipated Primary Completion Date :
Jun 10, 2021
Anticipated Study Completion Date :
Jul 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group A

Group A (conservative treatment): Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.

Drug: caffeine, paracetamol tablet
Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.

Active Comparator: group B

Group B (oral prednisolone): Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.

Drug: Oral prednisolone
Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.

Active Comparator: group C

Group C (oral pregabalin): Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.

Drug: oral Pregabalin
Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.
Other Names:
  • Lyrica
  • Outcome Measures

    Primary Outcome Measures

    1. pain intensity of headache [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 [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 [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 [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 [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. Total dose of rescue analgesia (ketorolac) consumption [from the onset of headache till 72 hours]

      total consumption of rescue analgesia (ketorolac) from the onset of headache till 72 hours

    7. time of relieve of Post dural puncture headache [from the onset of headache till 72 hours]

      time from start treatment till relieve symptoms

    Secondary Outcome Measures

    1. The number of participant with nausea, vomiting, diplopia, dizziness and neck stiffness [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      • Both gender.
    • Age: 18- 50 years old.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of medicine, Zagazig university Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Dina Salem, MD, faculty of medicine , Zagazig university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dina Abdelhameed Elsadek Salem, principal investigator, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT04662125
    Other Study ID Numbers:
    • 6324
    First Posted:
    Dec 10, 2020
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dina Abdelhameed Elsadek Salem, principal investigator, Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2021