Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

Study Overview
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Brief Summary
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This study will be conducted at Ain Shams University Hospital in Operating Theatre after ethical committe approval number (MS 32/ 2020). It is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,Eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .

Detailed Description
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Patients will be randomly divided into two equal groups: Group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline. Group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline. Upon patients' arrival into the operating room, peripheral oxygen saturation (SPO2), ECG, pulse rate (PR), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery. In a sitting position and with antiseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not not aware of the type of medications injected. Subsequently, the patients were put in the supine position, and given oxygen 3 L/minutes by nasal prongs.

Official Title
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Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache

Conditions
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Postdural Puncture Headache

Intervention / Treatment
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* Drug: Dexamethasone intravenous
* Drug: Dexamethasone intrathecal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia. Exclusion Criteria: Emergency surgeries. Patients with uncompensated heart diseases. Patients with coagulopathy. Presence of infection at site of injection of spinal anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous dexamethazone group<br>Patients receive intrathecal 3 ml heavy bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline,to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected. | Drug: Dexamethasone intravenous<br>* Evaluation of intravenous dexamethazone in prevention of postdural puncture headache<br>|
| Active Comparator: intrathecal dexamethazone group<br>Patients receive intrathecal 3 ml heavy bupivacaine 0.5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected. | Drug: Dexamethasone intrathecal<br>* Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of postdural puncture headache | prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively | 48 hours after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10 | 4 hours from injection of drug in subarachnoid space. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous dexamethazone, intrathecal dexamethazzone