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Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

Primary Purpose

Postdural Puncture Headache

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone intravenous
Dexamethasone intrathecal
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postdural Puncture Headache focused on measuring intravenous dexamethazone, intrathecal dexamethazzone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intravenous dexamethazone group

intrathecal dexamethazone group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of sensory block
Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10

Full Information

First Posted
January 12, 2021
Last Updated
January 20, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04709029
Brief Title
Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache
Official Title
Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Anticipated)
Primary Completion Date
May 20, 2021 (Anticipated)
Study Completion Date
June 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache
Keywords
intravenous dexamethazone, intrathecal dexamethazzone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double (participant and outcome assessor)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous dexamethazone group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
intrathecal dexamethazone group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravenous
Intervention Description
Evaluation of intravenous dexamethazone in prevention of postdural puncture headache
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intrathecal
Intervention Description
Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache
Primary Outcome Measure Information:
Title
Prevention of postdural puncture headache
Description
prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively
Time Frame
48 hours after spinal anesthesia
Secondary Outcome Measure Information:
Title
Duration of sensory block
Description
Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10
Time Frame
4 hours from injection of drug in subarachnoid space.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf Elagamy, E
Phone
oo2o224701953
Email
elagamy_ashraf@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia Elfawy
Phone
0020100401092
Email
daliamfawy@yahoo.com
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

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Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache

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