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Sphenopalatine Ganglion Block in Maxillofacial Surgeries

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sphenopalatine ganglion block using bupivacaine: xylocaine
Sphenopalatine ganglion block using normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Sphenopalatine ganglion block, Blood loss, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries

Sphenopalatine ganglion block using normal saline for maxillofacial surgeries

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Postoperative pain
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

Secondary Outcome Measures

Intraoperative opioid consumption
Opioid consumption in mg will be recorded
Blood loss
Intraoperative blood loss in mL will be measured using the gauze visual analogue

Full Information

First Posted
April 21, 2023
Last Updated
May 2, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05854537
Brief Title
Sphenopalatine Ganglion Block in Maxillofacial Surgeries
Official Title
Sphenopalatine Ganglion Block in Patients Undergoing Maxillofacial Surgeries: A Randomized Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Sphenopalatine ganglion block, Blood loss, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sphenopalatine ganglion block using normal saline for maxillofacial surgeries
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sphenopalatine ganglion block using bupivacaine: xylocaine
Intervention Description
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
Intervention Name(s)
Sphenopalatine ganglion block using normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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
Time Frame
6 hours postoperative
Secondary Outcome Measure Information:
Title
Intraoperative opioid consumption
Description
Opioid consumption in mg will be recorded
Time Frame
4 hours
Title
Blood loss
Description
Intraoperative blood loss in mL will be measured using the gauze visual analogue
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh Refaat, MD
Phone
+201001107173
Ext
+2
Email
avicen22@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Refaat
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Refaat
Phone
01001107173
Ext
+2
Email
avicen22@gmail.com

12. IPD Sharing Statement

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Sphenopalatine Ganglion Block in Maxillofacial Surgeries

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