Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
David R. Drover, Stanford University
ClinicalTrials.gov Identifier:
NCT00927888
First received: June 23, 2009
Last updated: June 6, 2012
Last verified: June 2012

June 23, 2009
June 6, 2012
August 2007
March 2010   (final data collection date for primary outcome measure)
Postoperative pain assessed on standard VAS scale [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Post-operative quality of recovery and pain followed up to 1 month
Postoperative pain assessed on standard VAS scale
Complete list of historical versions of study NCT00927888 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain, Postoperative
  • Drug: 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
  • Drug: Normal saline with Epi 1:100,000 (B block)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00927888
SU-05072009-2478, 9381
No
David R. Drover, Stanford University
Stanford University
Hospira, Inc.
Principal Investigator: David R. Drover Stanford University
Stanford University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP