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Postoperative Pain Course After Uvulopalatoplasty

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00918437
First received: June 9, 2009
Last updated: July 3, 2011
Last verified: June 2005
History of Changes
  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)

Resource links provided by NLM:

MedlinePlus related topics: Snoring
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain Intensity 0-10 Numerical Rating Scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Norwegian McGill Pain Questionnaire (NMPQ) [ Time Frame: 14 ] [ Designated as safety issue: No ]
  • Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Oral Health Impact Profile (OHIP-14) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Corahs Dental Anxiety Scale (CDAS) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 9, 2009
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Pain, Postoperative
Snoring
Postoperative Complications
Pathologic Processes
 Pain
Signs and Symptoms
Respiratory Sounds
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 19, 2013