Post Dural Puncture Headache
Conditions
Keywords
PDPH, Acetaminophen, Aminophylline, Dexamethasone
Brief summary
It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH.
Detailed description
Aim of the study is to compare intravenous aminophylline plus dexamethasone with intravenous acetaminophen and intravenous aminophylline on post dural puncture headache prevention after spinal anesthesia in terms of incidence of PDPH, VAS scores between the groups. . Patients will be randomly divided into two equal groups. (Group A1) who will receive aminophylline with acetaminophen infusion slowly and (Group A2) who will receive aminophylline with dexamethasone Infusion. Study variables will be noted in predesigned study proforma. Data will be entered on software SPSS version 26.0 and will be analyzed.
Interventions
DRUGInj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline
This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion.
DRUGInj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline
This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.
Sponsors
Sargodha Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
After approval of synopsis and approval from Institutional Ethical Review Board (IERB), 50 patients undergoing elective lower abdominopelvic and lower limb surgeries as per inclusion criteria in this study will be enrolled in this study.Two equal groups will be constituted. Informed consent will be taken from all patients after explaining the whole procedure, its merits, demerits, and alternate treatment options. Group A1 (n=25) will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. Group A2 (n=25) will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.Drugs will be given in infusion form at the end of the procedure and once daily for 3 days. Coded Drug infusions will be administered by an anesthetist blinded to study groups at the end of the procedure in operation theatre and once daily
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients from 18-40 years. * Elective surgery under spinal anesthesia * Those patients having history of PDPH * BMI≤ 35kg/m2 * American Society of Anesthesiologist (ASA) Physical Status I and II
Exclusion criteria
* History of known allergy or hypersensitivity against study drug * Emergency surgery * Obstetric patient * Failed spinal * Multiple attempts of spinal * Contraindication to Spinal Anesthesia * Chronic disease patients already taking opioids or NSAIDs * History of migraine or other headaches * Partially effective spinal anesthesia * Abnormal liver or kidney function, cardiovascular system diseases, respiratory system diseases and diseases of the nervous system * Intraoperative blood loss \>1000ml * Intraoperative hemodynamic instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH. | 3 days | Reduced Incidence of PDPH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone on post-dural puncture headache prevention after spinal anesthesia in terms of reduced severity of PDPH by VAS scores. | 3 days | ● Reduced serverity of PDPH by VAS scores by prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone in patients with previous history of PDPH. |
Countries
Pakistan
Outcome results
None listed