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

Sponsor:	ArthroCare Corporation
Collaborator:	Mayo Clinic
Information provided by:	ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00380458

Purpose

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	Intervention	Phase
Sleep Apnea, Obstructive	Device: Coblation (radiofrequency-based device)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by ArthroCare Corporation:

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.

Estimated Enrollment:	50
Study Start Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380458

Locations

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

ArthroCare Corporation

Mayo Clinic

Investigators

Principal Investigator:

John Bitner, MD

More Information

Publications:

Troell RJ, Powell NB, Riley RW, Li KK, Guilleminault C. Comparison of postoperative pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, and radiofrequency volumetric tissue reduction of the palate. Otolaryngol Head Neck Surg. 2000 Mar;122(3):402-9.

Quinn SJ, Daly N, Ellis PD. Observation of the mechanism of snoring using sleep nasendoscopy. Clin Otolaryngol Allied Sci. 1995 Aug;20(4):360-4.

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. Review.

Sher AE. An overview of sleep disordered breathing for the otolaryngologist. Ear Nose Throat J. 1999 Sep;78(9):694-5, 698-700, 703-6 passim. Review.

Responsible Party:	Wendy Winters, Manager Clinical Affairs, ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00380458 History of Changes
Other Study ID Numbers:	E-0406JM
Study First Received:	September 22, 2006
Last Updated:	May 13, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:

Obstructive
Sleep
Apnea
Pain

UPPP
Tonsillectomy
Narcotics

Additional relevant MeSH terms:

Apnea
Pain, Postoperative
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

Postoperative Complications
Pathologic Processes
Pain
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012