Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-06-20

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%. .

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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.

Conditions

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Postdural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

double (participant and outcome assessor)

Study Groups

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intravenous dexamethazone group

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone intravenous

Intervention Type DRUG

Evaluation of intravenous dexamethazone in prevention of postdural puncture headache

intrathecal dexamethazone group

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone intrathecal

Intervention Type DRUG

Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache

Interventions

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Dexamethasone intravenous

Evaluation of intravenous dexamethazone in prevention of postdural puncture headache

Intervention Type DRUG

Dexamethasone intrathecal

Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No