Health TrialsbyHealthPanel

Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy Surgeries

ConditionsTurbinate SurgerySphenopalatine Block
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing elective partial turbinectomy surgery

Age 18 years or older

Disqualifiers

Patient refusal

Kidney or liver impairment

Pregnant or breast-feeding women

Allergy to any of the drugs used in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: balanced anaesthesiaActive comparator 1 intervention
Group B: Lidocaine sprayExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Intraoperative

Secondary outcomes

1

Visual analog Score

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.

Time frame
Up to 12 hours post operative
2

Intraoperative Tachycardia

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

Time frame
Intraoperative
3

Intraoperative Hypertension

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

Time frame
Intraoperative
4

Total Postoperative Pethidine

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

Time frame
Up to 12 hours postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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