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Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

This study is currently recruiting patients

Verified by ArthroCare Corporation September 2006

Sponsors and Collaborators: ArthroCare Corporation
Mayo Clinic
Information provided by: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00380458


Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive Device: Coblation (radiofrequency-based device) Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by ArthroCare Corporation:
Primary Outcomes: Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary Outcomes: 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.
Expected Total Enrollment:  50

Study start: September 2006

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00380458

John Bitner, MD       Bitner.John@mayo.edu
Melissa Westergren      507-538-1392    westergren.melissa@mayo.edu

Minnesota
Mayo Clinic Rochester, Rochester,  Minnesota,  55905,  United States; Recruiting
John Bitner, MD   Bitner.John@mayo.edu 
Melissa Westergren   westergren.melissa@mayo.edu 

Study chairs or principal investigators

John Bitner, MD,  Principal Investigator,  Unaffiliated   

More Information

Publications

Troell RJ, Powell NB, Riley RW, Li KK, Guilleminault C. Comparison of postoperative pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, and radiofrequency volumetric tissue reduction of the palate. Otolaryngol Head Neck Surg. 2000 Mar;122(3):402-9.

Quinn SJ, Daly N, Ellis PD. Observation of the mechanism of snoring using sleep nasendoscopy. Clin Otolaryngol Allied Sci. 1995 Aug;20(4):360-4.

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. Review.

Sher AE. An overview of sleep disordered breathing for the otolaryngologist. Ear Nose Throat J. 1999 Sep;78(9):694-5, 698-700, 703-6 passim. Review.

Study ID Numbers:  E-0406JM
Last Updated:  September 22, 2006
Record first received:  September 22, 2006
ClinicalTrials.gov Identifier:  NCT00380458
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-09-29





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