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

Nasal Polyps Clinical Trial

Official title:

Infrazygomatic Versus Intranasal Injection Approaches of Sphinopalatine Ganglion Blockade Effect on Surgical Field in Functional Endoscopic Sinus Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04996576
• Other study ID #: sphinopalatine block in FESS
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Procedure:
• infrazygomatic approach sphinopalatine ganglion block
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
• intranasal injection approach of sphinopalatine ganglion block
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

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo
Egypt	Ain shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during the surgery
Secondary	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.	during the surgery and after the surgery( up to 24 hours)
Secondary	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	during the surgery and after the surgery( up to 24 hours)
Secondary	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	immediately after the surgery and 12 , 24 hours after the surgery
Secondary	postoperative epistaxis	epistaxis	after the surgery( up to 24 hours)
Secondary	postoperative infection	nasal infection	after the surgery( up to 24 hours)