Status:
COMPLETED
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 man...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00927888
Start Date
August 1 2007
End Date
August 1 2010
Last Update
May 19 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305