Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Sponsor

ArthroCare Corporation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00380458

Collaborator

Mayo Clinic (Other)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Device: Coblation (radiofrequency-based device)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period. []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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