Postoperative Pain Course After Uvulopalatoplasty

Completed

• Conditions: Snoring; Surgical Procedures, Operative; Pain, Postoperative; Quality of Life

• Registration Number: NCT00918437
• Lead Sponsor: Ullevaal 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).

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 Timeline

• Status Verified: 2005-06
• Study Start: 2005-06
• Primary Completion: 2008-05
• Study Completion: 2008-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Intensity 0-10 Numerical Rating Scale	14 days

Secondary Outcome Measures

Name	Time	Method
Norwegian McGill Pain Questionnaire (NMPQ)	14
Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)	14 days
Oral Health Impact Profile (OHIP-14)	14 days
Corahs Dental Anxiety Scale (CDAS)	1 day

Trial Locations

Locations (1)

Aleris Hospital; 🇳🇴 Oslo, Norway