Study to Evaluate Recovery From Postoperative Pain After... | NCT00380458

Studies
Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

NCT00380458

Sponsor

ArthroCare Corporation

Status

Withdrawn

Last Update Posted

Aug 26, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Sleep Apnea, Obstructive

Interventions

Coblation (radiofrequency-based device)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled. Study did not start.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 22, 2006

First Submission Date that Met QC Criteria

Sep 22, 2006

First Posted Date

Sep 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2015

Last Update Posted Date

Aug 26, 2015Estimated

Name	Class
Mayo Clinic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Coblation (radiofrequency-based device)	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Bitner, MD		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Rochester		Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10699818	Background	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.
8548973	Background

ID	Term
D012891	Sleep Apnea Syndromes
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic