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Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04709029
Enrollment
220
Registered
2021-01-14
Start date
2021-01-20
Completion date
2021-06-20
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache

Keywords

intravenous dexamethazone, intrathecal dexamethazzone

Brief summary

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

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.

Interventions

Evaluation of intravenous dexamethazone in prevention of postdural puncture headache

DRUGDexamethasone intrathecal

Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double (participant and outcome assessor)

Intervention model description

Parallel assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevention of postdural puncture headache48 hours after spinal anesthesiaprevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively

Secondary

MeasureTime frameDescription
Duration of sensory block4 hours from injection of drug in subarachnoid space.Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10

Countries

Egypt

Contacts

Primary ContactAshraf Elagamy, E
elagamy_ashraf@yahoo.comoo2o224701953
Backup ContactDalia Elfawy
daliamfawy@yahoo.com0020100401092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026