Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery

NCT00380458 | Withdrawn Phase 4

• 1 other identifier: E-0406JM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive; Sleep; Apnea; Pain; UPPP; Tonsillectomy; Narcotics

Outcome Measures

Primary Outcomes (1)

• Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.

Secondary Outcomes (3)

• 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.

Interventions

Coblation (radiofrequency-based device) DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ArthroCare Corporation: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• 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.

  PMID: 10699818 BACKGROUND

• 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.

  PMID: 8548973 BACKGROUND

• 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.

  PMID: 8464434 BACKGROUND

• 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.

  PMID: 8855039 BACKGROUND

• 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.

  PMID: 10502892 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Pain

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• John Bitner, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 26, 2006
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (1)