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Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927888
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : March 4, 2015
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
David R. Drover, Stanford University

Study Description
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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 management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine Block Drug: Placebo Phase 4

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). 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 - Bupivacaine Block
3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
 Drug: Bupivacaine Block
Bupivacaine local anesthesia block prior to start of FESS procedure.
Other Name: Local Block
Placebo Comparator: 2 - Placebo
Normal saline with Epi 1:100,000 (B block)
 Drug: Placebo
placebo is identical in appearance in comparison to active drug.
Other Name: Placebo saline injection


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Pain Assessed on Standard VAS Scale [ Time Frame: VAS Pain Score at 7 days ]
    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.


Secondary Outcome Measures :
  1. SNOT-20 Surgical Outcome Score [ Time Frame: 1-day ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927888


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: David R. Drover Stanford University
More Information
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Publications of Results:

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Responsible Party: David R. Drover, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00927888    
Other Study ID Numbers: SU-05072009-2478
First Posted: June 25, 2009    Key Record Dates
Results First Posted: March 4, 2015
Last Update Posted: May 19, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents