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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662125
• Other study ID #: 6324
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Headache
• Post-Dural Puncture Headache

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of medicine, Zagazig university	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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).
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	total dose of rescue analgesia	total amount of ketorolac	for 72 hours