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Postoperative Pain Course After Uvulopalatoplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918437
First Posted: June 11, 2009
Last Update Posted: July 6, 2011
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.
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
  Purpose
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
Snoring Surgical Procedures, Operative Pain, Postoperative Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Postoperative Pain Course and Intensity After Uvulopalatoplasty With Radiofrequency Knife (RAUP)

Further study details as provided by Oslo University Hospital:

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

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

Enrollment: 33
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
RAUP treatment
Patients referred to the hospital for a snoring problem

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00918437


Locations
Norway
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
  More Information

Publications:
Responsible Party: Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University Of Oslo
ClinicalTrials.gov Identifier: NCT00918437     History of Changes
Other Study ID Numbers: OES-002
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: July 6, 2011
Last Verified: June 2005

Keywords provided by Oslo University Hospital:
uvulopalatoplasty
postoperative pain
quality of life

Additional relevant MeSH terms:
Pain, Postoperative
Snoring
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Respiratory Sounds
Signs and Symptoms, Respiratory