Efficacy of Intranasal Sphenopalatine Ganglion Block by Lidocaine Spray for Partial Turbinectomy Surgeries
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- fentanyl doses
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 after anaesthesia induction and securing Endotracheal tube to end of surgery, excluding extubation time)
Arms & Interventions
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.
Intervention: Lidocaine spray (Drug)
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 24 hours postoperatively or until discharge.
Intervention: Balanced anesthesia (Drug)
Outcomes
Primary Outcomes
fentanyl doses
Time Frame: intraoperative
Total doses of fentanyl rescue doses intraoperative
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.
Secondary Outcomes
- Visual analog Score(up to 12 hours post operative)
- Time to Aldrete Score ≥9(Immediate postoperative period)
- 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)