Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

Not Applicable

• Conditions: Postdural Puncture Headache
• Interventions: Drug: Dexamethasone intrathecal; Drug: Dexamethasone intravenous

• Registration Number: NCT04709029
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-01-20
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Read More

Exclusion Criteria

• Emergency surgeries.
• Patients with uncompensated heart diseases.
• Patients with coagulopathy.
• Presence of infection at site of injection of spinal anesthesia.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrathecal dexamethazone group	Dexamethasone intrathecal	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.
intravenous dexamethazone group	Dexamethasone intravenous	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.

Primary Outcome Measures

Name	Time	Method
Prevention of postdural puncture headache	48 hours after spinal anesthesia	prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Duration of sensory block	4 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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt