Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

ArthroCare

Status and phase

Withdrawn

Phase 4

Conditions

Sleep Apnea, Obstructive

Treatments

Device: Coblation (radiofrequency-based device)

Study type

Interventional

Funder types

Other

Identifiers

NCT00380458

E-0406JM

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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