Postoperative Pain Course After Uvulopalatoplasty

NCT ID: NCT00918437

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Snoring Surgical Procedures, Operative Pain, Postoperative Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RAUP treatment

Patients referred to the hospital for a snoring problem

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Section of Dental Pharmacology and Pharmacotherapy, University Of Oslo

Principal Investigators

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Øystein S Eskeland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Lasse A Skoglund, DDS, DSci

Role: STUDY_CHAIR

University of Oslo

Per Skjelbred, MD, DDS

Role: STUDY_DIRECTOR

Ullevaal University Hospital

Locations

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Aleris Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.

Reference Type BACKGROUND
PMID: 1235985 (View on PubMed)

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

Reference Type BACKGROUND
PMID: 3670870 (View on PubMed)

Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

Reference Type BACKGROUND
PMID: 9332805 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3053270 (View on PubMed)

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. doi: 10.1111/j.1365-2648.1995.tb02722.x.

Reference Type BACKGROUND
PMID: 7745193 (View on PubMed)

Other Identifiers

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OES-002

Identifier Type: -

Identifier Source: org_study_id

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