Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

September 22, 2006

Last Updated Date

May 13, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00380458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Sleep Apnea, Obstructive

Intervention ^ICMJE

Device: Coblation (radiofrequency-based device)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00380458

Responsible Party

Wendy Winters, Manager Clinical Affairs, ArthroCare Corporation

Study ID Numbers ^ICMJE

E-0406JM

Study Sponsor ^ICMJE

ArthroCare Corporation

Collaborators ^ICMJE

Mayo Clinic

Investigators ^ICMJE

Principal Investigator:

John Bitner, MD

Unaffiliated

Information Provided By

ArthroCare Corporation

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP