ocal anaesthesia for prevention of pain after removal of tonsils in adult patients

Conditions: Adult patients undergoing tonsillectomy
MedDRA version: 14.0Level: PTClassification code 10044006Term: TonsillectomySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2011-003119-50-FI

Lead Sponsor: Vesa Kontinen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Elective tonsillectomy as outpatient
Operation under general anaesthesia
ASA class I and II
age over 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Tonsillar abscess under 2 weeks before operation, suspicion of malignant disease, disorder of coagulation, chronic pain medication, depression medication, allergy or contraindication for study drugs, body weigth <50 kg or >120 kg, inability to communicate in Finnish or Swedish language, inability to use the NRS pain scale

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To improve pain relief after tonsillectomy;Secondary Objective: No;Primary end point(s): Pain intensity when swallowing measured on <br>numeric rating scale (NRS) 0-10 (0 no pain, 10 worst possible pain) during 14 postoperative days. AUC (area under curve) of the pain intensity will be calculated.;Timepoint(s) of evaluation of this end point: First 14 postoperative days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Worst pain during two hours followup in PACU, and the amount of pain medication during 14 postoperative days.;Timepoint(s) of evaluation of this end point: Two hours (PACU) and 14 postoperative days (home).