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Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS

Primary Purpose

Nasal Polyps

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
infrazygomatic approach sphinopalatine ganglion block
intranasal injection approach of sphinopalatine ganglion block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nasal Polyps

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients of ASA physical status I-II.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ain shams university hospitals
  • Ain Shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intranasal injection approach sphinopalatine ganglion block

infrazygomatic approach sphinopalatine ganglion block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
postoperative epistaxis
epistaxis
postoperative infection
nasal infection

Full Information

First Posted
July 16, 2021
Last Updated
June 3, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04996576
Brief Title
Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS
Official Title
Infrazygomatic Versus Intranasal Injection Approaches of Sphinopalatine Ganglion Blockade Effect on Surgical Field in Functional Endoscopic Sinus Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intranasal injection approach sphinopalatine ganglion block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
infrazygomatic approach sphinopalatine ganglion block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
infrazygomatic approach sphinopalatine ganglion block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
intranasal injection approach of sphinopalatine ganglion block
Intervention Description
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
Primary Outcome Measure Information:
Title
surgical field quality
Description
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.
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
blood pressure
Description
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.
Time Frame
during the surgery and after the surgery( up to 24 hours)
Title
heart rate
Description
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
Time Frame
during the surgery and after the surgery( up to 24 hours)
Title
Postoperative pain
Description
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
Time Frame
immediately after the surgery and 12 , 24 hours after the surgery
Title
postoperative epistaxis
Description
epistaxis
Time Frame
after the surgery( up to 24 hours)
Title
postoperative infection
Description
nasal infection
Time Frame
after the surgery( up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of ASA physical status I-II. Exclusion Criteria: 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.
Facility Information:
Facility Name
Ain shams university hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS

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