Clinical trial NCT00918437: Postoperative Pain Course After Uvulopalatoplasty
Official title: Characterization of the Postoperative Pain Course and Intensity After Uvulopalatoplasty With Radiofrequency Knife (RAUP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Snoring
Surgical Procedures, Operative
Pain, Postoperative
Quality of Life
Keywords: uvulopalatoplasty
postoperative pain
quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-06-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of either sex, of Caucasian origin, between the age of 18 and 80, who are referred to the hospital for snoring that have been subjected to a sleep study indicating that uvulopalatoplasty might have a considerable affect on the snoring.

Brief summary: The aim of this study is to determine the postoperative course including effects on the quality of life following soft palate surgery with radiofrequency knife (RAUP).

Detailed description: For the treatment of social snoring one common treatment modality is the surgical reconstruction of the soft palate. The procedure is a routine operation performed at nearly all Ear-Nose- and Throat departments in Norway. The surgery is done with local anaesthesia in an out-patient setting where the patients' postoperative observation at the hospital is limited to 1-2 hours. As the surgery is done in the sensitive mucosa and palatopharyngeal musculature the postoperative course might be unpleasant. The patients are therefore in the need of regular postoperative pain treatment extending into the 2 first weeks after surgery.

At hospitals the uvulopalatoplasty is performed using a radiofrequency knife (RAUP) after the soft palate has been infiltrated with local anaesthesia (1% xylocain/adrenaline). The incision is done paramedialy to the uvular base and up into the musculature of the soft palate then making a smooth arch toward the pharyngeal tonsil upper limit. The then elongated uvula is amputated to about ½ cm. Occasionally, a suture is placed laterally and medially to lift the palate and prevent postoperative scaring. Coagulation is done if necessary with light bipolar diathermy.

As the postoperative course might be unpleasant after RAUP it is of interest to study the time course and intensity of pain after surgery when using the standardised postoperative pain treatment at OmniaSykehuset. The result will be useful in future studies looking at ways to improve the pain treatment after uvulopalatoplasty.

Eligibility criteria: Inclusion Criteria:

* Patients of either sex of Caucasian origin who are referred to the hospital for snoring that have been subjected to a sleep study indicating that uvulopalatoplasty might have a considerable affect on the snoring.

Exclusion Criteria:

* Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
* Patients with diabetes.
* Patients who due to age or communication skills are considered unable to complete patient forms.
* Professional evaluation suggests an alteration of the planned surgical area or treatment form.
* Known or assumed intolerance or hyper sensibility to diclofenac, codeine or paracetamol (standard postoperative analgesic treatment).
* Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7

Primary outcomes:
measure: Pain Intensity 0-10 Numerical Rating Scale
timeFrame: 14 days
Secondary outcomes:
measure: Norwegian McGill Pain Questionnaire (NMPQ)
timeFrame: 14
measure: Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)
timeFrame: 14 days
measure: Oral Health Impact Profile (OHIP-14)
timeFrame: 14 days
measure: Corahs Dental Anxiety Scale (CDAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Aleris Hospital
Study officials:
affiliation: University of Oslo
name: Øystein S Eskeland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Lasse A Skoglund, DDS, DSci
role: STUDY_CHAIR
affiliation: Ullevaal University Hospital
name: Per Skjelbred, MD, DDS
role: STUDY_DIRECTOR
References:
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citation: Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
citation: Corah NL. Dental anxiety. Assessment, reduction and increasing patient satisfaction. Dent Clin North Am. 1988 Oct;32(4):779-90.
citation: Kim HS, Schwartz-Barcott D, Holter IM, Lorensen M. Developing a translation of the McGill pain questionnaire for cross-cultural comparison: an example from Norway. J Adv Nurs. 1995 Mar;21(3):421-6. doi: 10.1111/j.1365-2648.1995.tb02722.x.