Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

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.

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Coblation (radiofrequency-based device)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No