Clinical trial NCT00380458: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive
Sleep
Apnea
Pain
UPPP
Tonsillectomy
Narcotics
Lead sponsor: ArthroCare Corporation
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2006-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary outcomes:
measure: Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
measure: Analysis of timing of self-administration of medication during the 21-day post-treatment period
measure: Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
name: John Bitner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/S0194-5998(00)70056-8.
citation: 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. doi: 10.1111/j.1365-2273.1995.tb00061.x.
citation: 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. doi: 10.1056/NEJM199304293281704.
citation: 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. doi: 10.1093/sleep/19.2.156.
citation: 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.