Sphenopalatine Ganglion BlockPhase 4NCT04657952
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients
A Phase 4 study testing Sphenopalatine Ganglion Block and Medical Treatment in people with Sphenopalatine Ganglion Block and Adrenaline, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache
- What is being tested?
- Sphenopalatine Ganglion Block and Medical Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2020to 20 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study
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.
- Conditions
- Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache, Orthopedic, Randomized Controlled Study
- Being tested
- Sphenopalatine Ganglion Block, Medical Treatment
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
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.
Medical TreatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical Treatment (paracetamol) | Active comparator | Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day. Receives: Drug: Medical Treatment |
| Sphenopalatine block | Experimental | Patients will receive sphenopalatine block Receives: Procedure: Sphenopalatine Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (3)
Onset of analgesia
The onset time till VAS≥ 4
Measured: 48 hours
Duration of analgesia
Duration with VAS< 4
Measured: 48 hours
Adverse events
Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start10 Dec 2020 (estimated)
- Primary completion10 May 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphenopalatine Ganglion BlockStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussen Gamal Almawardy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657952
- Sponsor's protocol ID
- 34268/11/20
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04657952
- Acronym / sponsor ID
- 34268/11/20
- Conditions
- Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache, Orthopedic, Randomized Controlled Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (estimated)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical Treatment (paracetamol) | Active comparator | Drug: Medical TreatmentPatients will receive paracetamol 1 gm every 6 hours daily intravenously for a day. |
| Sphenopalatine block | Experimental | Procedure: Sphenopalatine Ganglion BlockPatients will receive sphenopalatine block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine Ganglion BlockSphenopalatine 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. | Procedure or surgery | Sphenopalatine block |
| Medical TreatmentPatients 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. | Drug | Standard medical Treatment (paracetamol) |
Primary outcome
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours
Time frame: 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
3 secondary outcomes
Onset of analgesia
Time frame: 48 hours
Duration of analgesia
Time frame: 48 hours
Adverse events
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sphenopalatine Ganglion Block and Medical Treatment in people with Sphenopalatine Ganglion Block and Adrenaline, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.