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Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Primary Purpose

Sleep Apnea, Obstructive

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Coblation (radiofrequency-based device)
Sponsored by
ArthroCare Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Rochester

Outcomes

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.

Full Information

First Posted
September 22, 2006
Last Updated
August 25, 2015
Sponsor
ArthroCare Corporation
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00380458
Brief Title
Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled. Study did not start.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ArthroCare Corporation
Collaborators
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Coblation (radiofrequency-based device)
Primary Outcome Measure Information:
Title
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary Outcome Measure Information:
Title
Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
Title
Analysis of timing of self-administration of medication during the 21-day post-treatment period
Title
Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Bitner, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10699818
Citation
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. doi: 10.1016/S0194-5998(00)70056-8.
Results Reference
background
PubMed Identifier
8548973
Citation
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. doi: 10.1111/j.1365-2273.1995.tb00061.x.
Results Reference
background
PubMed Identifier
8464434
Citation
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. doi: 10.1056/NEJM199304293281704.
Results Reference
background
PubMed Identifier
8855039
Citation
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. doi: 10.1093/sleep/19.2.156.
Results Reference
background
PubMed Identifier
10502892
Citation
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.
Results Reference
background

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Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

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