Postoperative Pain Course After Uvulopalatoplasty

Sponsor
Ullevaal University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00918437
Collaborator
University of Oslo (Other)
33
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36
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterization of the Postoperative Pain Course and Intensity After Uvulopalatoplasty With Radiofrequency Knife (RAUP)
    Study Start Date :
    Jun 1, 2005
    Actual Primary Completion Date :
    May 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    RAUP treatment

    Patients referred to the hospital for a snoring problem

    Outcome Measures

    Primary Outcome Measures

    1. Pain Intensity 0-10 Numerical Rating Scale [14 days]

    Secondary Outcome Measures

    1. Norwegian McGill Pain Questionnaire (NMPQ) [14]

    2. Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ) [14 days]

    3. Oral Health Impact Profile (OHIP-14) [14 days]

    4. Corahs Dental Anxiety Scale (CDAS) [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aleris Hospital Oslo Norway NO-0264

    Sponsors and Collaborators

    • Ullevaal University Hospital
    • University of Oslo

    Investigators

    • Principal Investigator: Øystein S Eskeland, MD, University of Oslo
    • Study Chair: Lasse A Skoglund, DDS, DSci, University of Oslo
    • Study Director: Per Skjelbred, MD, DDS, Ullevaal University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00918437
    Other Study ID Numbers:
    • OES-002
    First Posted:
    Jun 11, 2009
    Last Update Posted:
    Jul 6, 2011
    Last Verified:
    Jun 1, 2005
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2011