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: April 19, 2016
Last verified: April 2016

June 23, 2009
April 19, 2016
August 2007
March 2010   (final data collection date for primary outcome measure)
Postoperative Pain Assessed on Standard VAS Scale [ Time Frame: VAS Pain Score at 7 days ] [ Designated as safety issue: No ]
Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.
Postoperative Pain Assessed on Standard VAS Scale
Complete list of historical versions of study NCT00927888 on ClinicalTrials.gov Archive Site
SNOT-20 Surgical Outcome Score [ Time Frame: 1-day ] [ Designated as safety issue: No ]

This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).

ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41-47

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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.

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). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS.

A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT & Endoscopic scores were compared between the two groups.

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: Bupivacaine Block
    Bupivacaine local anesthesia block prior to start of FESS procedure.
    Other Name: Local Block
  • Drug: Placebo
    placebo is identical in appearance in comparison to active drug.
    Other Name: Placebo saline injection
  • Active Comparator: 1 - Bupivacaine Block
    3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
    Intervention: Drug: Bupivacaine Block
  • Placebo Comparator: 2 - Placebo
    Normal saline with Epi 1:100,000 (B block)
    Intervention: Drug: Placebo
Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00927888
SU-05072009-2478
No
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David R. Drover, Stanford University
Stanford University
Hospira, Inc.
Principal Investigator: David R. Drover Stanford University
Stanford University
April 2016

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