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Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

This study has been withdrawn prior to recruitment.
Study NCT00380458.   Last updated on September 21, 2007.   Information provided by ArthroCare Corporation

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Descriptive Information Fields
Brief Title  Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
Official Title  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 a Coblation 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

Sleep apnea is a condition characterized by repeated episodes of paused or stopped breathing during sleep. Obstructive sleep apnea (OSA) occurs when respiratory effort is made but is unsuccessful due to upper airway obstruction or collapse. Most subjects presenting with OSA can be identified as having pathology that originates in the area of the soft palate and uvula. OSA is estimated to affect up to 4% of adults and is a potentially serious medical condition associated with cardiovascular disease, neuropsychiatric problems related to excessive daytime sleepiness and increased morbidity and mortality.

In some instances, OSA can be treated with conservative measures such as behavior modification including weight loss, sleep positioning, and avoidance of certain drugs. Continuous positive airway pressure (CPAP) is an alternative non-surgical treatment however, low long-term patient compliance rates limit its therapeutic use. Surgical procedures to enlarge or bypass the upper airway obstruction or collapse include tonsillectomy and uvulopalatopharyngoplasty (UPPP). Tonsillectomy and UPPP using monopolar electrocautery are effective, however, both are associated with severe post-operative discomfort and the heat generated by this modality can cause increased tissue damage and slower healing, potentially resulting in significant limitations in activity and diet. Recently, limited treatment of soft palatal tissues using Coblation under local anesthesia has shown promise as an alternate technique to relieve snoring in mild obstructive sleep apnea. At present however, postoperative recovery from pain with this technique has not been compared to conventional surgical methods using a controlled study design in an adult population.

This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using a COBLATION 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 Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary Outcome Measure  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.
Condition  Sleep Apnea, Obstructive
Intervention  Device: Coblation (radiofrequency-based device)
MEDLINE PMIDs 10699818,   8548973,   8464434,   8855039,   10502892
Links
Recruitment Information Fields
Recruitment Status  Withdrawn
Enrollment  50
Start Date  September 2006
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00380458
Organization ID E-0406JM
Secondary IDs ††
Study Sponsor  ArthroCare Corporation
Collaborators †† Mayo Clinic
Investigators 
Principal Investigator:     John Bitner, MD     Unaffiliated    
Information Provided By ArthroCare Corporation
Verification Date September 2007
First Received Date  September 22, 2006
Last Updated Date September 21, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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