- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299630
Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy Surgeries (SPG block)
Efficacy of Intranasal Sphenopalatine Ganglion Block by Lidocaine Spray for Partial Turbinectomy Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing turbinectomy usually suffer from chronic nasal congestion with wide spectrum of symptoms ranging from headache and breathing difficulty to sleep disorders and obstructive sleep apnea that could affect daily life .
Usually the surgery is done as a day case surgery in patients without major comorbidities. Points of concern to achieve smooth outcome and enhance recovery include pain management, better surgical field for both patient and surgeon satisfaction. One approach for these goals include regional nerve blocks for the innervation of the nose .
Spheno Palatine Ganglion (SPG) block was tested with a good results for blocking autonomic innervation and subsequent decrease in pain and opioid consumption. Blockage of SPG has many approaches either trans nasal or trans oral but both are invasive and needs trained hands to do Locally infiltrating lidocaine over nasal mucosa either by lidocaine spray or a lidocaine soaked gauze was also tested in nasal surgeries with good results but doubts about duration of action of lidocaine spray is a concern that may affect post-operative pain management Targeting SPG noninvasively by lidocaine spray is proposed technique that may offer easier approach for this type of surgeries. Although concerns about effectiveness of the spray to reach and block SPG was raised before , many studies examined this approach to control headache or trigeminal neuralgia with great success.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Abdallah soudi, M.D.
- Phone Number: 02- 01111228925
- Email: dr.soudi2014@med.asu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Ain Shams University Hospitals
-
Contact:
- Abdallah soudi, M.D.
- Phone Number: 02-01111228925
- Email: dr.soudi2014@med.asu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergoing elective partial turbinectomy surgery
- Age 18 years or older
Exclusion Criteria:
- Patient refusal
- Kidney or liver impairment
- Pregnant or breast-feeding women
- Allergy to any of the drugs used in the study
- OR time more than 90 minutes (defined as time from anaesthesia induction to end of surgery, excluding extubation time)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: balanced anaesthesia
Patients will receive standardized general anaesthesia: fentanyl 2 mcg/kg actual body weight (ABW) at induction, propofol 1.5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1 MAC for maintenance.
After intubation and bilateral application of xylometazoline nasal decongestant drops, morphine 0.05 mg/kg ABW will be administered intravenously.
All patients will additionally receive paracetamol 1g IV and ketorolac 30 mg IV in 100 mL normal saline intraoperatively.
Intraoperative rescue analgesia: fentanyl 50 mcg IV will be administered in response to tachycardia (heart rate exceeding 20% above individual baseline) or hypertension (systolic blood pressure exceeding 20% above individual baseline).
The rescue dose will be repeated after 10 minutes if the haemodynamic response criterion persists.
Postoperatively pethidine 50 mg IV will be administered for VAS score greater than 4. Regular paracetamol 1g IV will be given every 8 hours for up to 48 hours postoperatively or until discharge.
|
Standardized general anaesthesia with fentanyl 2 mcg/kg ABW at induction, propofol 1.5 mg/kg, rocuronium 0.6 mg/kg, sevoflurane 1 MAC for maintenance, followed by morphine 0.05 mg/kg ABW after intubation and nasal decongestant application.
Intraoperative rescue fentanyl 50 mcg IV for tachycardia or hypertension exceeding 20% above baseline, repeatable after 10 minutes.
Postoperative paracetamol 1g IV every 8 hours and pethidine 50 mg IV for VAS greater than 4.
|
|
Experimental: Lidocaine spray
Patients will receive identical standardized general anaesthesia as Group A. After intubation and bilateral application of xylometazoline nasal decongestant drops, intranasal lidocaine 10% spray will be applied bilaterally 10 puffs per nostril by directing the spray applicator parallel to the nasal floor in a postero-superior direction until resistance is felt, targeting the region of the sphenopalatine fossa.
Total lidocaine dose will be verified not to exceed 3 mg/kg ABW.
All patients will additionally receive paracetamol 1g IV and ketorolac 30 mg IV in 100 mL normal saline intraoperatively.
Intraoperative rescue analgesia and postoperative managment as group A.
|
Identical general anaesthesia induction and maintenance as the control arm.
After intubation and bilateral xylometazoline nasal decongestant: intranasal lidocaine 10% spray 10 puffs per nostril bilaterally, directed parallel to the nasal floor in a postero-superior direction until resistance is felt, targeting the sphenopalatine fossa.
Total dose not to exceed 3 mg/kg ABW.
Identical rescue and postoperative analgesia as control arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fentanyl doses
Time Frame: Intraoperative
|
Total cumulative intraoperative fentanyl rescue dose (mcg) administered in response to tachycardia defined as heart rate exceeding 20% above individual baseline or hypertension defined as systolic blood pressure exceeding 20% above individual baseline, given in increments of 50 mcg intravenously and repeatable every 10 minutes if the triggering criterion persists.
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog Score
Time Frame: Up to 12 hours post operative
|
Postoperative pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-Pain), a unidimensional 10-point numerical scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain outcome.
VAS-Pain will be assessed at four prespecified timepoints: recovery room arrival, 2 hours, 6 hours, and 12 hours postoperatively, by a blinded outcomes assessor.
Rescue analgesia with pethidine 50 mg intravenously will be administered for VAS-Pain score greater than 4.
|
Up to 12 hours post operative
|
|
Intraoperative Tachycardia
Time Frame: Intraoperative
|
Number of patients experiencing at least one episode of heart rate exceeding 20% above individual baseline intraoperative heart rate, recorded by continuous ECG monitoring with non-invasive readings documented every 5 minutes from T0 to end of surgery
|
Intraoperative
|
|
Intraoperative Hypertension
Time Frame: Intraoperative
|
Number of patients experiencing at least one episode of systolic blood pressure exceeding 20% above individual baseline systolic blood pressure, recorded by non-invasive blood pressure monitoring every 5 minutes from T0 to end of surgery
|
Intraoperative
|
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Total Postoperative Pethidine
Time Frame: Up to 12 hours postoperative
|
Cumulative dose of pethidine in milligrams administered intravenously in response to Visual Analogue Scale score greater than 4, recorded from recovery room arrival to 12 hours postoperatively by a blinded outcomes assessor
|
Up to 12 hours postoperative
|
|
Time to Extubation
Time Frame: Immediate postoperative period
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Time in minutes from end of surgery to successful tracheal extubation, assessed by the blinded outcomes assessor
|
Immediate postoperative period
|
|
Time to Aldrete Score ≥9
Time Frame: Immediate postoperative period
|
Time in minutes from tracheal extubation to attainment of a modified Aldrete score of 9 or above, indicating readiness for discharge from the post-anaesthesia care unit, assessed by the blinded outcomes assessor
|
Immediate postoperative period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU R239/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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