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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: caffeine, paracetamol tablet; Drug: Oral prednisolone; Drug: oral pregabalin

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Salem, MD; Phone Number: 002 01099333513; Email: dinamaghraby@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt
    • Faculty of medicine, Zagazig university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; 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.	Drug: caffeine, paracetamol tablet; 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.
Active Comparator: group B; 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.	Drug: 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. .
Active Comparator: group C; 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.	Drug: oral pregabalin; patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity of headache	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)	From onset of the headache (0 hour).
pain intensity of headache	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)	at 12 hours
pain intensity of headache	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)	at 24 hours
pain intensity of headache	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)	at 48 hours
pain intensity of headache	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)	at 72 hours
Headache intensity	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.	From onset of the headache (0 hour).
Headache intensity	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.	at 12 hours
Headache intensity	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.	at 24 hours
Headache intensity	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.	at 48 hours
Headache intensity	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.	at 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness	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)	for 72 hours
Associated symptoms of post dural puncture headache	The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness	for 72 hours
total dose of rescue analgesia	total amount of ketorolac	for 72 hours

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Dina Salem, MD, Faculty of Medicine , Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: oral prednisolone; oral pregabalin; post dural puncture headache (PDPH); lower limb surgeries
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Purinergic Antagonists; Purinergic Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Prednisolone; Acetaminophen; Pregabalin; Caffeine
• Other Study ID Numbers: 6324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No