Working… Menu

Postoperative Pain Course After Uvulopalatoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918437
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : July 6, 2011
University of Oslo
Information provided by:
Oslo University Hospital

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
Snoring Surgical Procedures, Operative Pain, Postoperative Quality of Life

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.

Layout table for study information
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 : June 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

RAUP treatment
Patients referred to the hospital for a snoring problem

Primary Outcome Measures :
  1. Pain Intensity 0-10 Numerical Rating Scale [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Norwegian McGill Pain Questionnaire (NMPQ) [ Time Frame: 14 ]
  2. Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ) [ Time Frame: 14 days ]
  3. Oral Health Impact Profile (OHIP-14) [ Time Frame: 14 days ]
  4. Corahs Dental Anxiety Scale (CDAS) [ Time Frame: 1 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918437

Layout table for location information
Aleris Hospital
Oslo, Norway, NO-0264
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University Of Oslo Identifier: NCT00918437     History of Changes
Other Study ID Numbers: OES-002
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: June 2005
Keywords provided by Oslo University Hospital:
postoperative pain
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Respiratory Sounds
Signs and Symptoms, Respiratory