Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
Status: | Withdrawn |
---|---|
Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
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
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.
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.
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.
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.
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
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