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
  Purpose

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.


Condition Intervention Phase
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)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927888

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Hospira, Inc.
Investigators
Principal Investigator: David R. Drover Stanford University
  More Information

No publications provided

Responsible Party: David R. Drover, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00927888     History of Changes
Other Study ID Numbers: SU-05072009-2478, 9381
Study First Received: June 23, 2009
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014