Clinical trial NCT04662125: Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: oral prednisolone
oral pregabalin
post dural puncture headache (PDPH)
lower limb surgeries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain intensity of headache
timeFrame: From onset of the headache (0 hour).
measure: pain intensity of headache
timeFrame: at 12 hours
measure: pain intensity of headache
timeFrame: at 24 hours
measure: pain intensity of headache
timeFrame: at 48 hours
measure: pain intensity of headache
timeFrame: at 72 hours
measure: Headache intensity
timeFrame: From onset of the headache (0 hour).
measure: Headache intensity
timeFrame: at 12 hours
measure: Headache intensity
timeFrame: at 24 hours
measure: Headache intensity
timeFrame: at 48 hours
measure: Headache intensity
timeFrame: at 72 hours
Secondary outcomes:
measure: Associated symptoms of post dural puncture headache
timeFrame: for 72 hours
measure: Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness
timeFrame: for 72 hours
measure: total dose of rescue analgesia
timeFrame: for 72 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine, Zagazig university
Study officials:
affiliation: faculty of medicine , Zagazig university
name: Dina Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: