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

NCT ID: NCT04662125

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2023-08-30

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

caffeine, paracetamol tablet

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Oral prednisolone

Intervention Type: DRUG

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. .

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.

Group Type: ACTIVE_COMPARATOR

oral pregabalin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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. .

Intervention Type: DRUG

oral pregabalin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dina Abdelhameed Elsadek Salem

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Salem, MD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine , Zagazig university

Locations

faculty of medicine, Zagazig university

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

6324

Identifier Type: -

Identifier Source: org_study_id