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
About this trial
This is an interventional treatment trial for Sphenopalatine Ganglion Block
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.
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
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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