Clinical trial NCT00927888: Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
Official title: The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2009-06-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The study subjects will be 18-70 year old.
2. The subjects will be American Society of Anesthesiology physical status I and II patients.
3. Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery.
4. The subjects should understand informed consent and study instructions, AND 5. The subjects should not participate in any other research protocols.

Exclusion Criteria:

1. Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.
2. Patients with pre-existing chronic pain of different etiology.
3. Patients taking prescription pain medications.
4. Patients taking antidepressant medications.
5. Patients taking over-the-counter pain medications within 48 hours of scheduled surgery.
6. Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively.
7. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents.
8. Patients with the history of arrhythmias or significant coronary artery disease.
9. Patients with psychological disorders.
10. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores.
11. Patients with the history of substance or alcohol abuse.
12. Patients with compromised renal and liver function.
13. Patients with abnormal coagulation status or platelet count less than 100,000.
14. Pregnant patients.
15. Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.
16. Other patients that may be excluded by the investigator, based on medical history and physical examination

Primary outcomes:
measure: Postoperative Pain Assessed on Standard VAS Scale
timeFrame: VAS Pain Score at 7 days
Secondary outcomes:
measure: SNOT-20 Surgical Outcome Score
timeFrame: 1-day
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David R. Drover
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13.