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Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients

Primary Purpose

Post-Dural Puncture Headache

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sphenopalatine ganglion block
paracetamol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache focused on measuring Sphenopalatine ganglion block, Post-Dural Puncture Headache

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Group A (Control group)

Group B (Sphenopalatine ganglion block group)

Arm Description

Patients will receive paracetamol 1 g thrice daily intravenously

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total analgesic consumption
total dose of ketorolac will be calculated

Full Information

First Posted
March 6, 2021
Last Updated
February 15, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04793490
Brief Title
Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients
Official Title
Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside. The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
Sphenopalatine ganglion block, Post-Dural Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Control group)
Arm Type
Other
Arm Description
Patients will receive paracetamol 1 g thrice daily intravenously
Arm Title
Group B (Sphenopalatine ganglion block group)
Arm Type
Active Comparator
Arm Description
patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone
Intervention Type
Procedure
Intervention Name(s)
Sphenopalatine ganglion block
Other Intervention Name(s)
SPGB
Intervention Description
Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
acetaminophen
Intervention Description
patients will receive paracetamol 1 g thrice daily intravenously
Primary Outcome Measure Information:
Title
Numeric rating pain score
Description
Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH
Time Frame
First 24 hours after the procedure
Secondary Outcome Measure Information:
Title
Total analgesic consumption
Description
total dose of ketorolac will be calculated
Time Frame
First 24 hours after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa M Mowafi, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
State/Province
Abassia
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients

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