Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380458
Recruitment Status : Withdrawn (No patients enrolled. Study did not start.)
First Posted : September 26, 2006
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
ArthroCare Corporation

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




Primary Outcome Measures :
  1. Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.

Secondary Outcome Measures :
  1. Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
  2. Analysis of timing of self-administration of medication during the 21-day post-treatment period
  3. Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380458


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
ArthroCare Corporation
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: John Bitner, MD
Publications:
Layout table for additonal information
Responsible Party: Wendy Winters, Manager Clinical Affairs, ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00380458    
Other Study ID Numbers: E-0406JM
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by ArthroCare Corporation:
Obstructive
Sleep
Apnea
Pain
UPPP
Tonsillectomy
Narcotics
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases