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
Results First Received: December 18, 2012  
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
Condition: Pain, Postoperative
Interventions: Drug: Bupivacaine Block
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Stanford medical center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Having unilateral FESS

Reporting Groups
  Description
Group 1 - Bupivacaine Block Active treatment group with application of bupivacaine block before FESS.
Group 2 - Placebo Saline Block This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.

Participant Flow:   Overall Study
    Group 1 - Bupivacaine Block     Group 2 - Placebo Saline Block  
STARTED     29     27  
COMPLETED     29     27  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 Bupivacaine Active treatment group with application of bupivacaine block before FESS.
Group 2 - Saline Placebo Group Saline substituted in block, placebo treatment group with application of saline block before FESS.
Total Total of all reporting groups

Baseline Measures
    Group 1 Bupivacaine     Group 2 - Saline Placebo Group     Total  
Number of Participants  
[units: participants]
  29     27     56  
Age  
[units: participants]
     
<=18 years     1     1     2  
Between 18 and 65 years     26     21     47  
>=65 years     2     5     7  
Age  
[units: years]
Mean (Full Range)
  49  
  (18 to 75)  
  42  
  (18 to 67)  
  45  
  (18 to 75)  
Gender  
[units: participants]
     
Female     8     7     15  
Male     21     20     41  
Region of Enrollment  
[units: participants]
     
United States     29     27     56  



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Drover, MD
Organization: Stanford University
phone: 6507250364
e-mail: ddrover@stanford.edu


Publications of Results:

Responsible Party: David R. Drover, Stanford University
ClinicalTrials.gov Identifier: NCT00927888     History of Changes
Other Study ID Numbers: SU-05072009-2478
Study First Received: June 23, 2009
Results First Received: December 18, 2012
Last Updated: April 19, 2016
Health Authority: United States: Institutional Review Board