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

Zagazig University

Status: Completed

Conditions: Analgesia

Treatments: Drug: caffeine, paracetamol tablet; Drug: oral pregabalin; Drug: Oral prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04662125

6324

Details and patient eligibility

About

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.

Full description

To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups. To detect any side effects of the study medications in all patient groups.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

63 participants in 3 patient groups

group A

Active Comparator group

Description:

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.

Treatment:

Drug: caffeine, paracetamol tablet

group B

Active Comparator group

Description:

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.

Treatment:

Drug: Oral prednisolone

group C

Active Comparator group

Description:

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.

Treatment:

Drug: oral pregabalin