Postoperative Pain Course After Uvulopalatoplasty

Quality of Life Clinical Trial

Official title:

Characterization of the Postoperative Pain Course and Intensity After Uvulopalatoplasty With Radiofrequency Knife (RAUP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918437
• Other study ID #: OES-002
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: July 3, 2011
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2005
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Quality of Life
• Snoring
• Surgical Procedures, Operative

Locations

Country	Name	City	State
Norway	Aleris Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Corah NL. Dental anxiety. Assessment, reduction and increasing patient satisfaction. Dent Clin North Am. 1988 Oct;32(4):779-90. Review. — View 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. — View Citation

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-99. — View Citation

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7. — View Citation

Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity 0-10 Numerical Rating Scale		14 days	No
Secondary	Norwegian McGill Pain Questionnaire (NMPQ)		14	No
Secondary	Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)		14 days	No
Secondary	Oral Health Impact Profile (OHIP-14)		14 days	No
Secondary	Corahs Dental Anxiety Scale (CDAS)		1 day	No