- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05854537
Sphenopalatine Ganglion Block in Maxillofacial Surgeries
Sphenopalatine Ganglion Block in Patients Undergoing Maxillofacial Surgeries: A Randomized Double-blinded Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sameh Refaat, MD
- Phone Number: +2 +201001107173
- Email: avicen22@gmail.com
Study Locations
-
-
القاهرة
-
Cairo, القاهرة, Egypt, 11728
- Ain Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients between 18 and 60 years undergoing maxillofacial surgeries
Exclusion Criteria:
- Patient refusal
- Patients with fracture nose
- Operation time of more than 4 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries
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.
|
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.
|
Placebo Comparator: Sphenopalatine ganglion block using normal saline for maxillofacial surgeries
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: 6 hours postoperative
|
Postoperative pain will be assessed by the Visual Analog Score (VAS) after 6 hours, the (VAS) is a scale from 1 to 10 where 1 is the least pain and 10 is the worst pain
|
6 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative opioid consumption
Time Frame: 4 hours
|
Opioid consumption in mg will be recorded
|
4 hours
|
Blood loss
Time Frame: 4 hours
|
Intraoperative blood loss in mL will be measured using the gauze visual analogue
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sameh Refaat, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Cysts
- Connective Tissue Diseases
- Mucinoses
- Ganglion Cysts
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
Other Study ID Numbers
- R 67/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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