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Different Approaches for the Management of Post-dural Puncture Headache

Primary Purpose

Post-Dural Puncture Headache

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

sphenopalatine ganglion block

paracetamol

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

The ASA physical condition І-П
the patient underwent CS under spinal anesthesia
The headache developed within 5 days after the dural puncture
There is no different explanation for the headache

Exclusion Criteria:

coagulopathy
history of nasal bleeding
nasal polyp
septal deviation
local anesthetics reaction

Sites / Locations

Sohag faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

lidocaine group

bupivacaine group

conservative group

Arm Description

Outcomes

Primary Outcome Measures

postdural puncture headache

visual analog scale

Secondary Outcome Measures

Full Information

NCT ID

NCT05253014

First Posted

February 5, 2022

Last Updated

February 15, 2022

Sponsor

Bahaa Mohammed Refaie

1. Study Identification

Unique Protocol Identification Number

NCT05253014

Brief Title

Different Approaches for the Management of Post-dural Puncture Headache

Official Title

Comparative Study Between Different Approaches for the Management of Post-dural Puncture Headache

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bahaa Mohammed Refaie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Dural Puncture Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lidocaine group

Arm Type

Active Comparator

Arm Title

bupivacaine group

Arm Type

Active Comparator

Arm Title

conservative group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

sphenopalatine ganglion block

Intervention Description

block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache

Intervention Type

Drug

Intervention Name(s)

paracetamol

Intervention Description

intravenous paracetamol every 8 hours

Primary Outcome Measure Information:

Title

postdural puncture headache

Description

visual analog scale

Time Frame

within five days after the dural puncture

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

20 - 45 years old female with PDPH after cesarean section using spinal anesthesia

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The ASA physical condition І-П the patient underwent CS under spinal anesthesia The headache developed within 5 days after the dural puncture There is no different explanation for the headache Exclusion Criteria: coagulopathy history of nasal bleeding nasal polyp septal deviation local anesthetics reaction

Facility Information:

Facility Name

Sohag faculty of medicine

City

Sohag

ZIP/Postal Code

82524

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Different Approaches for the Management of Post-dural Puncture Headache

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