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
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
Dr Yarapotini Sneha Chowdary
Kasturba Medical College; Manipal