Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Bupivacaine

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