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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04996576
Other study ID # sphinopalatine block in FESS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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