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:
|Information provided by:
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.
|Sleep Apnea, Obstructive
||Device: Coblation (radiofrequency-based device)
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:
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
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.
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
- 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.
- 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
Please refer to this study by ClinicalTrials.gov identifier
Mayo Clinic Rochester, Rochester,
United States; Recruiting
Study chairs or principal investigators
John Bitner, MD, Principal Investigator, Unaffiliated
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
Quinn SJ, Daly N, Ellis PD. Observation of the mechanism of snoring using sleep nasendoscopy. Clin Otolaryngol Allied Sci.
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:
September 22, 2006
Record first received:
September 22, 2006
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-09-29