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Clinical Trials/CTRI/2025/09/095447
CTRI/2025/09/095447
Not yet recruiting
Phase 4

A Randomized Double-Blind Clinical Trial to Compare the Effectiveness of Intranasal and Transoral Approaches of Sphenopalatine Ganglion Block for Postoperative Analgesia Following Functional Endoscopic Sinus Surgery

Dr Yarapotini Sneha Chowdary1 site in 1 country50 target enrollmentStarted: October 7, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Yarapotini Sneha Chowdary
Enrollment
50
Locations
1
Primary Endpoint
compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score

Overview

Brief Summary

All the patients will recieve standard General anesthesia

Participants will be randomly assigned to Group I intranasal or Group T transoral using a computer-generated block randomization

Allocation will be concealed via sequentially numbered, opaque, sealed envelopes prepared by an independent researcher

Transoral Approach - A 24G bent needle is inserted near the second molar, 1.5 to 2 ml of local anesthetic is injected and repeated on the opposite side

Intranasal Approach - Cotton pledgets soaked in 2 ml of local anesthetic are inserted along the superior border of middle terminate to reach posterior nasopharyngeal wall where SPG lies. Left for 5 to 10 min for anesthetic absorption and then repeated on the opposite side

Following a 10 min wait post block, conventional septoplasty will be performed

After extubation, patient will be assessed by a blinded observer for post operative pain using a VAS at intervals 0 min, 30 min, 1 hr, 2 hr, 4 hr and 6 hr.

If VAS score is greater than 4, rescue analgesia with IV diclofenac 75 mg will be given

Time to 1st rescue analgesia and total post operative analgesia consumption will be recorded.

Post operative complications like nausea, vomiting, headache, visual disturbances will be monitored for 24 hr post procedure

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • American Society of Anaesthesiologists Physical Status I and II.

Exclusion Criteria

  • Localized infection at the site of SPG block application.
  • Hypersensitivity to local anesthetics.
  • Patients with chronic pain or long-term opioid use might confound pain assessment.
  • Coagulopathies or on-going anticoagulant or antiplatelet therapy Pregnant or breastfeeding patients Patients with altered mental status or cognitive impairments Patients with chronic liver/kidney diseases.

Outcomes

Primary Outcomes

compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score

Time Frame: 6 hours post surgery

Secondary Outcomes

  • complications associated with intranasal or transoral approaches.

Investigators

Sponsor
Dr Yarapotini Sneha Chowdary
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Yarapotini Sneha Chowdary

Kasturba Medical College; Manipal

Study Sites (1)

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