Postdural Puncture Headache
Conditions
Brief summary
In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.
Detailed description
A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility. Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.
Interventions
OTHERSaline placebo
nebulization of saline placebo in 4 ml) twice daily for three days.
DRUGDexmedetomidine
ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
\- Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.
Exclusion criteria
* Hypersensitivity of dexmedetomidine, neostigmine or atropine * Overactive thyroid gland * Myasthenia gravis * Closed angle glaucoma * High blood pressure and coronary artery disease. * withdrawal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale score (VAS) ≤3 within 72 hour. | 3 days | change in visual analog scale score (VAS )for the assessment of the degree of headache (with 0 representing no headache and 10 cm representing the worst imaginable headache). a visual analog scale score ≤3 within 72 hour after intervention will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Epidural blood patch | Day 4 | Epidural blood patch will be done in failed study drugs, traditional treatment and taking consent from patients after 72h from intervention |
| Occurence of neck stiffness | 3 days | If there is occurance of neck stiffness after start of PDPH |
Countries
Egypt
Outcome results
None listed