NCT04709029

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%. .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 12, 2021

Last Update Submit

January 20, 2021

Conditions

Postdural Puncture Headache

Keywords

intravenous dexamethazoneintrathecal dexamethazzone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Duration of sensory block

    4 hours from injection of drug in subarachnoid space.

Study Arms (2)

intravenous dexamethazone group

ACTIVE COMPARATOR

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

intrathecal dexamethazone group

ACTIVE COMPARATOR

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

Interventions

Dexamethasone intravenousDRUG

Evaluation of intravenous dexamethazone in prevention of postdural puncture headache

intravenous dexamethazone group
Dexamethasone intrathecalDRUG

Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache

intrathecal dexamethazone group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia
  • Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Ashraf Elagamy, E

CONTACT

oo2o224701953elagamy_ashraf@yahoo.com

Dalia Elfawy

CONTACT

0020100401092daliamfawy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double (participant and outcome assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor Anesthesia,Intensive care and pain management

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

January 20, 2021

Primary Completion

May 20, 2021

Study Completion

June 20, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

EG(1)