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NCT Number: NCT04996576

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

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

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university, Cairo, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. surgical field quality

    Time frame: during the surgery

    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 outcomes

  1. blood pressure

    Time frame: 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.

  2. heart rate

    Time frame: 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

  3. Postoperative pain

    Time frame: 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

  4. postoperative epistaxis

    Time frame: after the surgery( up to 24 hours)

    epistaxis

  5. postoperative infection

    Time frame: after the surgery( up to 24 hours)

    nasal infection

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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