Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04709029
• Other study ID #: FMASU MS 32/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: Ashraf Elagamy, E
• Phone: oo2o224701953
• Email: elagamy_ashraf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%. .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: June 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Drug:
• Dexamethasone intravenous
Evaluation of intravenous dexamethazone in prevention of postdural puncture headache
• Dexamethasone intrathecal
Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.