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

NCT04996576 | Completed

• 1 other identifier: sphinopalatine block in FESS
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation.

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• surgical field quality

  bloodless clear surgical field will be assessed for each side by surgeon using five categories categories. 1. = uncontrolled bleeding. 2. = severe bleeding, surgical conditions distorted immediately afterwards suctioning. 3. = moderate bleeding, frequent suctioning required, visibility of the surgical field is moderate. 4. = slight bleeding, occasional suctioning required, visibility of the surgical field is good. 5. = no bleeding almost bloodless surgical field.

  during the surgery

Secondary Outcomes (5)

• blood pressure

  during the surgery and after the surgery( up to 24 hours)

• heart rate

  during the surgery and after the surgery( up to 24 hours)

• Postoperative pain

  immediately after the surgery and 12 , 24 hours after the surgery

• postoperative epistaxis

  after the surgery( up to 24 hours)

• postoperative infection

  after the surgery( up to 24 hours)

Study Arms (2)

intranasal injection approach sphinopalatine ganglion block

ACTIVE COMPARATOR

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.

Procedure: intranasal injection approach of sphinopalatine ganglion block

infrazygomatic approach sphinopalatine ganglion block

ACTIVE COMPARATOR

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

Procedure: infrazygomatic approach sphinopalatine ganglion block

Interventions

infrazygomatic approach sphinopalatine ganglion block PROCEDURE

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

infrazygomatic approach sphinopalatine ganglion block

intranasal injection approach of sphinopalatine ganglion block PROCEDURE

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

intranasal injection approach sphinopalatine ganglion block

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of ASA physical status I-II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain shams university hospitals

Cairo, 11591, Egypt

Location

Ain Shams university

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 9, 2021
• Study Start: September 15, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

EG (2)