Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean (PDPH)

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Hydrocortisone; Other: oral fluids; Drug: Caffeine; Drug: Acetaminophen; Drug: Pregabalin 100Mg Oral Cap; Drug: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03910088

CairoU11112017

Details and patient eligibility

About

Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.

Full description

The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent elective cesarean section under spinal anesthesia.
• Patients aged 18 to 40 years old.
• Patients classified as ASA I or II.

Exclusion criteria

• Patients with known sensitivity to any of the used drugs.
• Patients classified as ASA III or more.
• Preeclampsia.
• Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours

Treatment:

Drug: Diclofenac

Drug: Caffeine

Drug: Acetaminophen

Other: oral fluids

Pregabalin

Active Comparator group

Description:

received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours

Treatment:

Drug: Pregabalin 100Mg Oral Cap

Drug: Diclofenac

Drug: Caffeine

Drug: Acetaminophen

Other: oral fluids

Hydrocortisone

Active Comparator group

Description:

received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.

Treatment:

Drug: Diclofenac

Drug: Caffeine

Drug: Hydrocortisone

Drug: Acetaminophen

Other: oral fluids