NCT05253014

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

February 5, 2022

Last Update Submit

February 15, 2022

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • postdural puncture headache

    visual analog scale

    within five days after the dural puncture

Study Arms (3)

lidocaine group

ACTIVE COMPARATOR
Procedure: sphenopalatine ganglion block

bupivacaine group

ACTIVE COMPARATOR
Procedure: sphenopalatine ganglion block

conservative group

ACTIVE COMPARATOR
Drug: paracetamol

Interventions

sphenopalatine ganglion blockPROCEDURE

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

bupivacaine grouplidocaine group
paracetamolDRUG

intravenous paracetamol every 8 hours

conservative group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details20 - 45 years old female with PDPH after cesarean section using spinal anesthesia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion BlockAcetaminophen

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of anesthesia and ICu

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 23, 2022

Study Start

January 1, 2018

Primary Completion

October 30, 2020

Study Completion

December 30, 2020

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

EG(1)