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Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

Primary Purpose

Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sphenopalatine Ganglion Block
Medical Treatment
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sphenopalatine Ganglion Block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to the orthopedic department
  • Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
  • American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria:

  • Patient refusal or uncooperative.
  • Patients with uncontrollable hypertension.
  • Patient with known coagulopathy.
  • Patient with nasal septal deviation, polyp, history of nasal bleeding.
  • Patient with allergy to local anesthetics
  • American Society of Anesthesiologists physical status>2.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard medical Treatment (paracetamol)

    Sphenopalatine block

    Arm Description

    Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.

    Patients will receive sphenopalatine block

    Outcomes

    Primary Outcome Measures

    Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours
    Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours. VAS ranges from 0 to 10; 10 with worse outcome

    Secondary Outcome Measures

    Onset of analgesia
    The onset time till VAS≥ 4
    Duration of analgesia
    Duration with VAS< 4
    Adverse events
    Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate

    Full Information

    First Posted
    November 30, 2020
    Last Updated
    December 6, 2020
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04657952
    Brief Title
    Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients
    Official Title
    Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 10, 2020 (Anticipated)
    Primary Completion Date
    May 10, 2021 (Anticipated)
    Study Completion Date
    May 20, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta 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 aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache, Orthopedic, Randomized Controlled Study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard medical Treatment (paracetamol)
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.
    Arm Title
    Sphenopalatine block
    Arm Type
    Experimental
    Arm Description
    Patients will receive sphenopalatine block
    Intervention Type
    Procedure
    Intervention Name(s)
    Sphenopalatine Ganglion Block
    Intervention Description
    Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine & adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.
    Intervention Type
    Drug
    Intervention Name(s)
    Medical Treatment
    Intervention Description
    Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.
    Primary Outcome Measure Information:
    Title
    Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours
    Description
    Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours. VAS ranges from 0 to 10; 10 with worse outcome
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Onset of analgesia
    Description
    The onset time till VAS≥ 4
    Time Frame
    48 hours
    Title
    Duration of analgesia
    Description
    Duration with VAS< 4
    Time Frame
    48 hours
    Title
    Adverse events
    Description
    Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Admitted to the orthopedic department Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries. American Society of Anesthesiologists (ASA) physical status I and II. Exclusion Criteria: Patient refusal or uncooperative. Patients with uncontrollable hypertension. Patient with known coagulopathy. Patient with nasal septal deviation, polyp, history of nasal bleeding. Patient with allergy to local anesthetics American Society of Anesthesiologists physical status>2.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data will be available upon reasonable request
    IPD Sharing Access Criteria
    3 months after completing the study

    Learn more about this trial

    Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

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