Different Approaches for the Management of Post-dural Puncture Headache

February 15, 2022 updated by: Bahaa Mohammed Refaie

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: lidocaine group
Procedure: sphenopalatine ganglion block
block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache
ACTIVE_COMPARATOR: bupivacaine group
Procedure: sphenopalatine ganglion block
block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache
ACTIVE_COMPARATOR: conservative group
Drug: paracetamol
intravenous paracetamol every 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postdural puncture headache
Time Frame: within five days after the dural puncture
visual analog scale
within five days after the dural puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahaa Mohammed Refaie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

February 5, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (ACTUAL)

February 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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