Nasal PolypsNCT04996576
Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS
A study testing infrazygomatic approach sphinopalatine ganglion block and intranasal injection approach of sphinopalatine ganglion block in people with Nasal Polyps, run by Ain Shams University at 2 sites in Egypt.
Trial summary
This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- infrazygomatic approach sphinopalatine ganglion block and intranasal injection approach of sphinopalatine ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Sep 2021to 1 May 2022
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of ASA physical status I-II.
Who cannot join
- Patients of ASA physical status III or above.
- Patients with clinically significant cardiovascular, pulmonary or hepatic disease.
- Patients with bleeding diathesis or on anticoagulant therapy.
- Age less than 21 years.
- Mentally disabled patients.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams university hospitals
Cairo, 11591
Ain Shams university
Cairo, 11591
About this study
Official title: Infrazygomatic Versus Intranasal Injection Approaches of Sphinopalatine Ganglion Blockade Effect on Surgical Field in Functional Endoscopic Sinus Surgeries
This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation.
Read the detailed description
Functional endoscopic sinus surgery (FESS) is a minimally invasive, effective surgical technique that is commonly used to treat chronic rhino sinusitis and nasal polyposis.
Intra-operative bleeding obscures the surgical view and increases the likelihood of iatrogenic complications. There are many factors that can affect the amount of bleeding experienced during surgery including both patient and surgical factors. These include severe forms of chronic sinusitis with nasal polyposis which is associated with increased vascularity, use of anticoagulant therapy, bleeding disorders, active infection, vascular tumor on the surgical site and revision surgery may affect bleeding on surgical site.
Sphenopalatine ganglion (SPG) is the main sensory innervation to the nasal mucosa.
The Sphenopalatine ganglion block (SPGB) is one of the regional anesthetic techniques that were used effectively before removal of nasal packing and in patients undergoing endoscopic sinus surgery under general anaesthesia to control bleeding or for postoperative analgesia
- Conditions
- Nasal Polyps
- Being tested
- infrazygomatic approach sphinopalatine ganglion block, intranasal injection approach of sphinopalatine ganglion block
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrazygomatic approach sphinopalatine ganglion blockProcedure or surgery
A lateral fluoroscopic view of the face will be obtained with the C-arm by superimposing the mandibular rami on top of each other spinal needle with a slightly bent tip is inserted with lateral fluoroscopic guidance. superiorly and medially toward the sphinopalatine fossa.
(AP) view intermittently obtained to check the depth 0.2 mL of contrast material will be injected to rule out intravascular spread and confirm spread of the dye within the sphinopalatine fossa .Local anesthetic, such as 2 mL of 1% lidocaine will be slowly injected
intranasal injection approach of sphinopalatine ganglion blockProcedure or surgery
method 2 ml Lidocaine with Epinephrine 1/200000 will be injected posterior to meatus of middle concha to block terminal nerve branches of sphinopalatine ganglia
| Study group | Role | What they receive |
|---|---|---|
| intranasal injection approach sphinopalatine ganglion block | Active comparator | Then in one nasal side (intranasal injection group) will be chosen randomly (right or left) by closed envelopes method 2 ml Lidocaine with Epinephrine 1/200000 will be injected posterior to meatus of middle concha to block terminal nerve branches of sphinopalatine ganglia and 2 ml saline will be injected in the same place in the other nasal side (to prevent surgeon expectation of intra nasal group by seeing injection site in one side only) by surgeon assistant who will be blind for the injection content. Receives: Procedure: intranasal injection approach of sphinopalatine ganglion block |
| infrazygomatic approach sphinopalatine ganglion block | Active comparator | In the side saline only given by the intranasal injection A lateral fluoroscopic view of the face will be obtained with the C-arm by superimposing the mandibular rami on top of each other spinal needle with a slightly bent tip is inserted with lateral fluoroscopic guidance. superiorly and medially toward the sphinopalatine fossa.
(AP) view intermittently obtained to check the depth 0.2 mL of contrast material will be injected to rule out intravascular spread and confirm spread of the dye within the sphinopalatine fossa .Local anesthetic, such as 2 mL of 1% lidocaine will be slowly injected Receives: Procedure: infrazygomatic approach sphinopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical field quality
bloodless clear surgical field will be assessed for each side by surgeon using five categories categories.
- = uncontrolled bleeding.
- = severe bleeding, surgical conditions distorted immediately afterwards suctioning.
- = moderate bleeding, frequent suctioning required, visibility of the surgical field is moderate.
- = slight bleeding, occasional suctioning required, visibility of the surgical field is good.
- = no bleeding almost bloodless surgical field.
Measured: during the surgery
Secondary outcomes (5)
blood pressure
Intraoperative blood pressure changes will be observed every 10 minutes and will be compared between the two sides in the unit mmHg Postoperatively, patients will be observed in the postanesthesia care unit (PACU). During the observation period, arterial blood pressure will be continuously monitored every 15 minutes for 1 hour. Patients meeting PACU discharge criteria will be transferred to the surgical ward. blood pressure will be reported every 4 hours for 24 hours.
Measured: during the surgery and after the surgery( up to 24 hours)
heart rate
intraoperative heart rate will be compared between the two sides in the unit beat per minute Postoperatively, patients will be observed in the postanesthesia care unit (PACU). During the observation period, heart rate will be continuously monitored every 15 minutes for 1 hour. Patients meeting PACU discharge criteria will be transferred to the surgical ward. heart rate will be reported every 4 hours for 24 hours
Measured: during the surgery and after the surgery( up to 24 hours)
Postoperative pain
Postoperative pain will be assessed and patient will be asked to compare between the two nasal sides, in the PACU and at 6, 12 and 24 hours after surgery with a 10-cm visual analog scale (VAS) (0 = no pain, 10 = most severe pain). Pain severity will be divided into 3 groups: mild, score of <4; moderate, score of 4 to 6; and severe >6
Measured: immediately after the surgery and 12 , 24 hours after the surgery
postoperative epistaxis
epistaxis
Measured: after the surgery( up to 24 hours)
postoperative infection
nasal infection
Measured: after the surgery( up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Sep 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Elswefi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996576
- Sponsor's protocol ID
- sphinopalatine block in FESS
- Status last verified
- Jun 2022
- First submitted
- 16 Jul 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrazygomatic Versus Intranasal Injection Approaches of Sphinopalatine Ganglion Blockade Effect on Surgical Field in Functional Endoscopic Sinus Surgeries
- ClinicalTrials.gov ID
- NCT04996576
- Acronym / sponsor ID
- sphinopalatine block in FESS
- Conditions
- Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Aug 2021 (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.
This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation.
Detailed description
Functional endoscopic sinus surgery (FESS) is a minimally invasive, effective surgical technique that is commonly used to treat chronic rhino sinusitis and nasal polyposis.
Intra-operative bleeding obscures the surgical view and increases the likelihood of iatrogenic complications. There are many factors that can affect the amount of bleeding experienced during surgery including both patient and surgical factors. These include severe forms of chronic sinusitis with nasal polyposis which is associated with increased vascularity, use of anticoagulant therapy, bleeding disorders, active infection, vascular tumor on the surgical site and revision surgery may affect bleeding on surgical site.
Sphenopalatine ganglion (SPG) is the main sensory innervation to the nasal mucosa.
The Sphenopalatine ganglion block (SPGB) is one of the regional anesthetic techniques that were used effectively before removal of nasal packing and in patients undergoing endoscopic sinus surgery under general anaesthesia to control bleeding or for postoperative analgesia
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal injection approach sphinopalatine ganglion block | Active comparator | Procedure: intranasal injection approach of sphinopalatine ganglion blockThen in one nasal side (intranasal injection group) will be chosen randomly (right or left) by closed envelopes method 2 ml Lidocaine with Epinephrine 1/200000 will be injected posterior to meatus of middle concha to block terminal nerve branches of sphinopalatine ganglia and 2 ml saline will be injected in the same place in the other nasal side (to prevent surgeon expectation of intra nasal group by seeing injection site in one side only) by surgeon assistant who will be blind for the injection content. |
| infrazygomatic approach sphinopalatine ganglion block | Active comparator | Procedure: infrazygomatic approach sphinopalatine ganglion blockIn the side saline only given by the intranasal injection A lateral fluoroscopic view of the face will be obtained with the C-arm by superimposing the mandibular rami on top of each other spinal needle with a slightly bent tip is inserted with lateral fluoroscopic guidance. superiorly and medially toward the sphinopalatine fossa. (AP) view intermittently obtained to check the depth 0.2 mL of contrast material will be injected to rule out intravascular spread and confirm spread of the dye within the sphinopalatine fossa .Local anesthetic, such as 2 mL of 1% lidocaine will be slowly injected |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of ASA physical status I-II.
Key exclusion criteria (5 listed)
- Patients of ASA physical status III or above.
- Patients with clinically significant cardiovascular, pulmonary or hepatic disease.
- Patients with bleeding diathesis or on anticoagulant therapy.
- Age less than 21 years.
- Mentally disabled patients.
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 |
|---|---|---|
| infrazygomatic approach sphinopalatine ganglion blockA lateral fluoroscopic view of the face will be obtained with the C-arm by superimposing the mandibular rami on top of each other spinal needle with a slightly bent tip is inserted with lateral fluoroscopic guidance. superiorly and medially toward the sphinopalatine fossa. (AP) view intermittently obtained to check the depth 0.2 mL of contrast material will be injected to rule out intravascular spread and confirm spread of the dye within the sphinopalatine fossa .Local anesthetic, such as 2 mL of 1% lidocaine will be slowly injected | Procedure or surgery | infrazygomatic approach sphinopalatine ganglion block |
| intranasal injection approach of sphinopalatine ganglion blockmethod 2 ml Lidocaine with Epinephrine 1/200000 will be injected posterior to meatus of middle concha to block terminal nerve branches of sphinopalatine ganglia | Procedure or surgery | intranasal injection approach sphinopalatine ganglion block |
Primary outcome
surgical field quality
Time frame: during the surgery
bloodless clear surgical field will be assessed for each side by surgeon using five categories categories. 1. = uncontrolled bleeding. 2. = severe bleeding, surgical conditions distorted immediately afterwards suctioning. 3. = moderate bleeding, frequent suctioning required, visibility of the surgical field is moderate. 4. = slight bleeding, occasional suctioning required, visibility of the surgical field is good. 5. = no bleeding almost bloodless surgical field.
5 secondary outcomes
blood pressure
Time frame: during the surgery and after the surgery( up to 24 hours)
heart rate
Time frame: during the surgery and after the surgery( up to 24 hours)
Postoperative pain
Time frame: immediately after the surgery and 12 , 24 hours after the surgery
postoperative epistaxis
Time frame: after the surgery( up to 24 hours)
postoperative infection
Time frame: after the surgery( up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrazygomatic approach sphinopalatine ganglion block and intranasal injection approach of sphinopalatine ganglion block in people with Nasal Polyps, run by Ain Shams University at 2 sites in Egypt.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surgical field quality (time frame: during the surgery). 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 7 Jun 2022.