Different Approaches for the Management of Post-dural Puncture Headache

NCT ID: NCT05253014

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Post-Dural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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lidocaine group

Group Type ACTIVE_COMPARATOR

sphenopalatine ganglion block

Intervention Type PROCEDURE

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

bupivacaine group

Group Type ACTIVE_COMPARATOR

sphenopalatine ganglion block

Intervention Type PROCEDURE

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

conservative group

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

intravenous paracetamol every 8 hours

Interventions

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sphenopalatine ganglion block

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

Intervention Type PROCEDURE

paracetamol

intravenous paracetamol every 8 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bahaa Mohammed Refaie

OTHER

Sponsor Role lead

Responsible Party

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Bahaa Mohammed Refaie

lecturer of anesthesia and ICu

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sohag faculty of medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2223

Identifier Type: -

Identifier Source: org_study_id

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