NCT04793490

Brief Summary

The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

February 16, 2022

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

March 6, 2021

Last Update Submit

February 15, 2022

Conditions

Post-Dural Puncture Headache

Keywords

Sphenopalatine ganglion blockPost-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • Numeric rating pain score

    Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH

    First 24 hours after the procedure

Secondary Outcomes (1)

  • Total analgesic consumption

    First 24 hours after the procedure

Study Arms (2)

Group A (Control group)

OTHER

Patients will receive paracetamol 1 g thrice daily intravenously

Drug: paracetamol

Group B (Sphenopalatine ganglion block group)

ACTIVE COMPARATOR

patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone

Procedure: Sphenopalatine ganglion block

Interventions

Sphenopalatine ganglion blockPROCEDURE

Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone

Also known as: SPGB
Group B (Sphenopalatine ganglion block group)
paracetamolDRUG

patients will receive paracetamol 1 g thrice daily intravenously

Also known as: acetaminophen
Group A (Control group)

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients ASA I or II post caesarean section
  • Body weight between 60-100 kg
  • Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.

You may not qualify if:

  • Patient refusal to participate in the study
  • Body mass index \>35kg/m2
  • Patients with :coagulopathy ,nasal septal deviation,polyp
  • History of nasal bleeding
  • Allergy to local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Abassia, 11591, 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 Officials

  • Marwa M Mowafi, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia ,principal Investigator

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 11, 2021

Study Start

March 15, 2021

Primary Completion

November 25, 2021

Study Completion

December 5, 2021

Last Updated

February 16, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)