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Trial record 36 of 243 for:    Recruiting, Not yet recruiting, Available Studies | Headache

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean (PDPH)

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ClinicalTrials.gov Identifier: NCT03910088
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Nesrine El-Refai, Cairo University

Brief Summary:
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Drug: Pregabalin 100Mg Oral Cap Drug: Hydrocortisone Drug: Acetaminophen Other: oral fluids Drug: Caffeine Drug: Diclofenac Phase 4

Detailed Description:
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Placebo Comparator: control group
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Name: Paracetamol

Other: oral fluids
giving oral fluids to maintain good hydration
Other Name: good hydration

Drug: Caffeine
giving a drug to relieve post-dural puncture headache

Drug: Diclofenac
giving a drug to relieve post-dural puncture headache

Active Comparator: Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
Drug: Pregabalin 100Mg Oral Cap
giving a drug to relieve post-dural puncture headache

Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Name: Paracetamol

Other: oral fluids
giving oral fluids to maintain good hydration
Other Name: good hydration

Drug: Caffeine
giving a drug to relieve post-dural puncture headache

Drug: Diclofenac
giving a drug to relieve post-dural puncture headache

Active Comparator: Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
Drug: Hydrocortisone
Giving drug to relieve post-dural puncture headache

Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Name: Paracetamol

Other: oral fluids
giving oral fluids to maintain good hydration
Other Name: good hydration

Drug: Caffeine
giving a drug to relieve post-dural puncture headache

Drug: Diclofenac
giving a drug to relieve post-dural puncture headache




Primary Outcome Measures :
  1. Assessment of pain using Visual Analogue Scale [ Time Frame: the first 48 hours following treatment ]
    Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment


Secondary Outcome Measures :
  1. Assessment of the amount of rescue drug [ Time Frame: The first 48 hours following treatment ]
    Total dose of nalbuphine given in each group..

  2. incidence of side effects of the studied drug [ Time Frame: the first 48 hours following treatment ]
    incidence of Somnolence

  3. incidence of side effect of the studied drug [ Time Frame: the first 48 hours following treatment ]
    incidence of dizziness



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study group is the pregnant females undergoing cesarean section
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who underwent elective cesarean section under spinal anesthesia.
  • Patients aged 18 to 40 years old.
  • Patients classified as ASA I or II.

Exclusion Criteria:

  • Patients with known sensitivity to any of the used drugs.
  • Patients classified as ASA III or more.
  • Preeclampsia.
  • Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910088


Locations
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Egypt
Cairo University Recruiting
Cairo, Zamalek, Egypt, 11586
Contact: Nesrine Refai    1001775633    nesrinerefai@hotmail.com   
Sponsors and Collaborators
Cairo University

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Responsible Party: Nesrine El-Refai, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03910088     History of Changes
Other Study ID Numbers: CairoU11112017
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nesrine El-Refai, Cairo University:
spinal
cesarean
pregabalin
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Headache Disorders, Secondary
Headache Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Diclofenac
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Pregabalin
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents