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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
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
David R. Drover, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: Bupivacaine Block
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 29   27   56 
[Units: Participants]
<=18 years   1   1   2 
Between 18 and 65 years   26   21   47 
>=65 years   2   5   7 
[Units: Years]
Mean (Full Range)
 (18 to 75) 
 (18 to 67) 
 (18 to 75) 
[Units: Participants]
Female   8   7   15 
Male   21   20   41 
Region of Enrollment 
[Units: Participants]
United States   29   27   56 

  Outcome Measures

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

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
No text entered.

  More Information

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
First Submitted: June 23, 2009
First Posted: June 25, 2009
Results First Submitted: December 18, 2012
Results First Posted: March 4, 2015
Last Update Posted: May 19, 2016