Postoperative PainNCT05854537
Sphenopalatine Ganglion Block in Maxillofacial Surgeries
A study testing Sphenopalatine ganglion block using bupivacaine: xylocaine and Sphenopalatine ganglion block using normal saline in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Patients will be divided into 2 groups, 22 each. Group A will receive a sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils, then by local anesthetic injected by a cannula into both nostrils. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sphenopalatine ganglion block using bupivacaine: xylocaine and Sphenopalatine ganglion block using normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2023to 27 Aug 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 60 years undergoing maxillofacial surgeries
Who cannot join
- Patient refusal
- Patients with fracture nose
- Operation time of more than 4 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sphenopalatine Ganglion Block in Patients Undergoing Maxillofacial Surgeries: A Randomized Double-blinded Study
Patients will be divided into 2 groups, 22 each. Group A will receive a sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils, then by local anesthetic injected by a cannula into both nostrils. Group B will undergo the same procedure, but normal saline will be used instead of the local anesthetic.
Read the detailed description
The local anesthetic mixture will be prepared using a 1:1 combination of xylocaine 2% and bupivacaine 0.5% in a 10 mL syringe. On admission to the operating room (OR) blood pressure, heart rate, and oxygen saturation at room air will be recorded.
The patient will then lie supine with slight neck extension, with nostrils pointing upwards.
Group A patients will have the cotton swab soaked in the local anesthetic (LA) medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then the investigators will inject 1.5 ml of medication via a syringe connected to a 20 gauge (G) catheter into their nostrils bilaterally.
Group B patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will also be done with normal saline.
After 5 minutes a standard anesthetic technique will be followed. After preoxygenation for three minutes, anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and atracurium besylate 0.5 mg/kg will provide muscle relaxation. The patient will be monitored using the 4 standard general anesthesia monitors; pulse oximeter, capnogram, non-invasive blood pressure (NIBP), and the 5 lead ECG for the whole operation, in addition to the bi spectral index (BIS) till the end of the surgery, extubation, and transfer to the post-anesthesia care unit (PACU).
Patient blood pressure and heart rate will be monitored throughout the whole operation and after the operation in the PACU.
The patient's postoperative pain will be assessed by the visual analog scale (VAS) score from 0 = (no pain) to 10 = (worst pain).
Intraoperative bleeding will be estimated using the gauze visual analog. The time to the first analgesic request was recorded. It was defined as the time from recovery until VAS score greater than 4.
During the study, the following data will be recorded:
Demographic data \& patients' characteristics (age, body weight, body mass index (BMI) Type of surgery (Maxillary, mandibular, or combined)
Intraoperative hemodynamics: Mean blood pressure and heart rate were recorded at the following timings:
T0: preoperatively as a baseline T1: After intubation T2: After skin incision T-end: At skin closure Postoperatively: In the PACU Intraoperative mean anesthetic concentration (MAC) is measured every 30 minutes till the end of surgery.
Total intraoperative fentanyl consumption in micrograms, where the patient will receive additional doses of fentanyl (1ug/kg) when mean arterial pressure (MAP)> 100 The duration of surgery (time from skin incision till the end of skin closure) Recovery time in minutes (time interval between discontinuation of isoflurane and extubation.) VAS every 4 hours postoperatively till 12 hours.
- Conditions
- Postoperative Pain
- Being tested
- Sphenopalatine ganglion block using bupivacaine: xylocaine, Sphenopalatine ganglion block using normal saline
- Keywords
- Sphenopalatine ganglion block, Blood loss, Pain
- Medical subject headings
- Pain, Postoperative, Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine ganglion block using bupivacaine: xylocaineProcedure or surgery
Patients will have the cotton swab soaked in the LA medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally.
Sphenopalatine ganglion block using normal salineProcedure or surgery
Patients will have the cotton swab soaked in normal saline introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml normal saline injected via a syringe connected to a 20G catheter into their nostrils bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries | Active comparator | Patients will have the cotton swab soaked in the LA medication (bupivacaine: lidocaine) introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally. Receives: Procedure: Sphenopalatine ganglion block using bupivacaine: xylocaine |
| Sphenopalatine ganglion block using normal saline for maxillofacial surgeries | Placebo comparator | Patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will be done by normal saline as well. Receives: Procedure: Sphenopalatine ganglion block using normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed by the Visual Analog Scale (VAS) after 2 hours, the (VAS is a scale from 1 to 10 where 1 is the least pain, and 10 is the worst pain
Measured: 2 hours postoperative
Secondary outcomes (2)
Intraoperative opioid consumption
Opioid consumption in mg will be recorded
Measured: 4 hours
Blood loss
Intraoperative blood loss in mL will be measured using the gauze visual analogue
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start20 Aug 2023
- Primary completion20 Jul 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Refaat, Ain Shams University
- Investigators
- Sameh Refaat, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854537
- Sponsor's protocol ID
- R 67/2023
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2023
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block in Patients Undergoing Maxillofacial Surgeries: A Randomized Double-blinded Study
- ClinicalTrials.gov ID
- NCT05854537
- Acronym / sponsor ID
- R 67/2023
- Conditions
- Postoperative Pain
- Keywords
- Sphenopalatine ganglion block, Blood loss, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 11 May 2023 (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.
Patients will be divided into 2 groups, 22 each. Group A will receive a sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils, then by local anesthetic injected by a cannula into both nostrils. Group B will undergo the same procedure, but normal saline will be used instead of the local anesthetic.
Detailed description
The local anesthetic mixture will be prepared using a 1:1 combination of xylocaine 2% and bupivacaine 0.5% in a 10 mL syringe. On admission to the operating room (OR) blood pressure, heart rate, and oxygen saturation at room air will be recorded.
The patient will then lie supine with slight neck extension, with nostrils pointing upwards.
Group A patients will have the cotton swab soaked in the local anesthetic (LA) medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then the investigators will inject 1.5 ml of medication via a syringe connected to a 20 gauge (G) catheter into their nostrils bilaterally.
Group B patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will also be done with normal saline.
After 5 minutes a standard anesthetic technique will be followed. After preoxygenation for three minutes, anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and atracurium besylate 0.5 mg/kg will provide muscle relaxation. The patient will be monitored using the 4 standard general anesthesia monitors; pulse oximeter, capnogram, non-invasive blood pressure (NIBP), and the 5 lead ECG for the whole operation, in addition to the bi spectral index (BIS) till the end of the surgery, extubation, and transfer to the post-anesthesia care unit (PACU).
Patient blood pressure and heart rate will be monitored throughout the whole operation and after the operation in the PACU.
The patient's postoperative pain will be assessed by the visual analog scale (VAS) score from 0 = (no pain) to 10 = (worst pain).
Intraoperative bleeding will be estimated using the gauze visual analog. The time to the first analgesic request was recorded. It was defined as the time from recovery until VAS score greater than 4.
During the study, the following data will be recorded:
Demographic data \& patients' characteristics (age, body weight, body mass index (BMI) Type of surgery (Maxillary, mandibular, or combined)
Intraoperative hemodynamics: Mean blood pressure and heart rate were recorded at the following timings:
T0: preoperatively as a baseline T1: After intubation T2: After skin incision T-end: At skin closure Postoperatively: In the PACU Intraoperative mean anesthetic concentration (MAC) is measured every 30 minutes till the end of surgery.
Total intraoperative fentanyl consumption in micrograms, where the patient will receive additional doses of fentanyl (1ug/kg) when mean arterial pressure (MAP)> 100 The duration of surgery (time from skin incision till the end of skin closure) Recovery time in minutes (time interval between discontinuation of isoflurane and extubation.) VAS every 4 hours postoperatively till 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries | Active comparator | Procedure: Sphenopalatine ganglion block using bupivacaine: xylocainePatients will have the cotton swab soaked in the LA medication (bupivacaine: lidocaine) introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally. |
| Sphenopalatine ganglion block using normal saline for maxillofacial surgeries | Placebo comparator | Procedure: Sphenopalatine ganglion block using normal salinePatients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will be done by normal saline as well. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 18 and 60 years undergoing maxillofacial surgeries
Key exclusion criteria (3 listed)
- Patient refusal
- Patients with fracture nose
- Operation time of more than 4 hours
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 block using bupivacaine: xylocainePatients will have the cotton swab soaked in the LA medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally. | Procedure or surgery | Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries |
| Sphenopalatine ganglion block using normal salinePatients will have the cotton swab soaked in normal saline introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml normal saline injected via a syringe connected to a 20G catheter into their nostrils bilaterally. | Procedure or surgery | Sphenopalatine ganglion block using normal saline for maxillofacial surgeries |
Primary outcome
Postoperative pain
Time frame: 2 hours postoperative
Postoperative pain will be assessed by the Visual Analog Scale (VAS) after 2 hours, the (VAS is a scale from 1 to 10 where 1 is the least pain, and 10 is the worst pain
2 secondary outcomes
Intraoperative opioid consumption
Time frame: 4 hours
Blood loss
Time frame: 4 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 2 Nov 2026.
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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.
Sameh Refaat principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine ganglion block using bupivacaine: xylocaine and Sphenopalatine ganglion block using normal saline in people with Postoperative Pain, run by Ain Shams University at 1 site 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 3 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Postoperative pain (time frame: 2 hours postoperative). 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 2 Nov 2026.