Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics
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.
Interventions
DEVICECoblation (radiofrequency-based device)
Sponsors
Mayo Clinic
ArthroCare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed