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

Not Applicable

Completed

• Conditions: Nasal Polyps

• Registration Number: NCT04996576
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-09
• Study Start: 2021-09-15
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
surgical field quality	during the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	immediately after the surgery and 12 , 24 hours after the surgery	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 infection	after the surgery( up to 24 hours)	nasal infection
postoperative epistaxis	after the surgery( up to 24 hours)	epistaxis
blood pressure	during the surgery and after the surgery( up to 24 hours)	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	during the surgery and after the surgery( up to 24 hours)	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

Trial Locations

Locations (2)

Ain shams university hospitals; 🇪🇬 Cairo, Egypt

Ain Shams university; 🇪🇬 Cairo, Egypt