Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00380458
• Other study ID #: E-0406JM
• Status: Withdrawn
• Phase: Phase 4
• First received: September 22, 2006
• Last updated: August 25, 2015

Study information

• Verified date: August 2015
• Source: ArthroCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Coblation (radiofrequency-based device)

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
ArthroCare Corporation	Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary	Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
Secondary	Analysis of timing of self-administration of medication during the 21-day post-treatment period
Secondary	Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.