Peter H. Hwang
Postoperative Pain and Functional Patient Outcomes after Functional Endoscopic Sinus Surgery.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Drug: 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) vs Normal saline with Epi 1:100,000 (B block)
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
The study subjects will be 18-70 year old, American Society of Anesthesiology physical status I and II patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery. The subjects should understand informed consent and study instructions, and not participate in any other research protocols.
Key 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
Additional Study Details
Official Title:
The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes after Functional Endoscopic Sinus Surgery.Anticipated start date:
8/28/2007Lead Sponsor:
Stanford UniversityCollaborator(s):
- Hospira Inc.
Investigator(s):
Study Type:
InterventionalPurpose:
OtherAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
UnspecifiedPrimary Outcomes:
- Postoperative pain assessed on standard VAS scale
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
60More Information
Secondary ID(s):
- 9381
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/12/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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