Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Coblation (radiofrequency-based device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coblation (radiofrequency-based device)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics