Sphenopalatine Ganglion Block in Maxillofacial Surgeries

NCT ID: NCT05854537

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2023-12-27

Brief Summary

Patients will be divided into 2 groups, 30 each. Group A will receive 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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sphenopalatine ganglion block using bupivacaine: xylocaine

Intervention Type: PROCEDURE

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 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.

Group Type: PLACEBO_COMPARATOR

Sphenopalatine ganglion block using normal saline

Intervention Type: PROCEDURE

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.

Interventions

Sphenopalatine ganglion block using bupivacaine: xylocaine

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.

Intervention Type: PROCEDURE

Sphenopalatine ganglion block using normal saline

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Refaat

Lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Refaat

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

R 67/2023

Identifier Type: -

Identifier Source: org_study_id