Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy Surgeries

NCT07299630 | Recruiting Phase 3 DMC

• 1 other identifier: FMASU R239/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal turbinectomy surgeries are usually done as day case surgeries as most patients are young with unremarkable comorbidities. However, considerations are still present towards patients of old age or those suffering from obesity or obstructive sleep apnea (OSA). Different techniques are still evolving to improve handling those patients to decrease complications, enhance recovery after surgery and increase patient satisfaction. Targeting sphenopalatine ganglion block by topical local anesthesia is a proposed technique that could help by decreasing peri-operative opioid consumption.

Conditions

Turbinate Surgery; Sphenopalatine Block

Keywords

SPG block; lidocaine spray; partial turbinectomy surgery

Outcome Measures

Primary Outcomes (1)

• Fentanyl doses

  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 Outcomes (6)

• Visual analog Score

  Up to 12 hours post operative

• Intraoperative Tachycardia

  Intraoperative

• Intraoperative Hypertension

  Intraoperative

• Total Postoperative Pethidine

  Up to 12 hours postoperative

• Time to Extubation

  Immediate postoperative period

Study Arms (2)

balanced anaesthesia

ACTIVE COMPARATOR

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.

Drug: Balanced anesthesia

Lidocaine spray

EXPERIMENTAL

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.

Drug: Lidocaine spray

Interventions

Balanced anesthesia DRUG

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.

balanced anaesthesia

Lidocaine spray DRUG

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.

Lidocaine spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective partial turbinectomy surgery
• Age 18 years or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Balanced Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Abdallah soudi, M.D.

CONTACT

02- 01111228925; dr.soudi2014@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A two-anesthesiologist model will be employed to achieve investigator blinding. Anesthesiologist 1 (unblinded) will open the sealed randomization envelope and administer the allocated intervention after induction and nasal decongestant application, then withdraw from all further patient care and data recording for that case. Anesthesiologist 2 (blinded) will assume full intraoperative management after intervention administration is complete, recording all vital signs, haemodynamic events, and rescue analgesic doses without knowledge of group allocation. A third anesthesiologist (Anesthesiologist 3, blinded) with no involvement in intraoperative care will conduct all postoperative assessments including VAS-Pain scoring, pethidine administration, and recovery timing from recovery room arrival to 12 hours postoperatively. Patient blinding is ensured by administering all group-specific interventions after induction of general anaesthesia and loss of consciousness. The operating surgeon is
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 23, 2025
• Study Start: December 20, 2025
• Primary Completion: April 25, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)