Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

Detailed Description
-----------------
The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS. A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT & Endoscopic scores were compared between the two groups.

Official Title
-----------------
The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Bupivacaine Block
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study subjects will be 18-70 year old. The subjects will be American Society of Anesthesiology physical status I and II patients. Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery. The subjects should understand informed consent and study instructions, AND 5. The subjects should not participate in any other research protocols. Exclusion Criteria: Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis. Patients with pre-existing chronic pain of different etiology. Patients taking prescription pain medications. Patients taking antidepressant medications. Patients taking over-the-counter pain medications within 48 hours of scheduled surgery. Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents. Patients with the history of arrhythmias or significant coronary artery disease. Patients with psychological disorders. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores. Patients with the history of substance or alcohol abuse. Patients with compromised renal and liver function. Patients with abnormal coagulation status or platelet count less than 100,000. Pregnant patients. Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine. Other patients that may be excluded by the investigator, based on medical history and physical examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 - Bupivacaine Block<br>3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) | Drug: Bupivacaine Block<br>* Bupivacaine local anesthesia block prior to start of FESS procedure.<br>* Other names: Local Block;|
| Placebo Comparator: 2 - Placebo<br>Normal saline with Epi 1:100,000 (B block) | Drug: Placebo<br>* placebo is identical in appearance in comparison to active drug.<br>* Other names: Placebo saline injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Assessed on Standard VAS Scale | Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible. | VAS Pain Score at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-20 Surgical Outcome Score | This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units). ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41-47 | 1-day |