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Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

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ClinicalTrials.gov Identifier: NCT00380458
Recruitment Status : Withdrawn (No patients enrolled. Study did not start.)
First Posted : September 26, 2006
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
ArthroCare Corporation

Tracking Information
First Submitted Date  ICMJE September 22, 2006
First Posted Date  ICMJE September 26, 2006
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
  • Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
  • Analysis of timing of self-administration of medication during the 21-day post-treatment period
  • Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
Official Title  ICMJE Prospective, Randomized, Controlled Clinical Trial to Evaluate Recovery From Post-operative Pain in Adults After Sleep Apnea Surgery Using a Coblation Device Compared to Electrocautery
Brief Summary The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.
Detailed Description This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. The amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. Further, timing of self-medication will be analyzed separately.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE Device: Coblation (radiofrequency-based device)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
0
Original Enrollment  ICMJE
 (submitted: September 22, 2006)
50
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is > or = 18 years of age
  • Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
  • Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
  • Subject signs IRB-approved informed consent form
  • Subject is willing and able to complete required follow-up.

Exclusion Criteria:

  • Subject has had a previous tonsillectomy
  • Subject's RDI >40
  • Subject has a history of chronic use of narcotic pain medications
  • Subject is unable to take liquid opioid analgesics
  • Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380458
Other Study ID Numbers  ICMJE E-0406JM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wendy Winters, Manager Clinical Affairs, ArthroCare Corporation
Study Sponsor  ICMJE ArthroCare Corporation
Collaborators  ICMJE Mayo Clinic
Investigators  ICMJE
Principal Investigator: John Bitner, MD
PRS Account ArthroCare Corporation
Verification Date August 2015

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