Bupivacaine in Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
A placebo-controlled and double-blind study is planned according to current legislation and ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after tonsillectomy, and 50% receive 0.9% sodium chloride. Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding, fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2, 3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with mixed models statistics and the results will be published in a peer-based journal.

Official Title
-----------------
Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Sodium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years Exclusion Criteria: Known allergy to local anesthetics. Patients using painkillers in the form of opioids fixed before inclusion in the study. People who have a lot of pain often have more pain after known painful stimuli, such as surgery. This is known as the phenomenon of central sensitization and opioid-induced hyperalgesia and will probably contribute to great heterogeneity within the groups. Because very few people use opioids regularly from those who have an isolated tonsillectomy performed, it can make it difficult to detect any differences between the groups, and the number is far too low to be able to perform stratified analyzes on only these people. Persons weighing less than 10 kg. Persons over the age of 18 who are not competent to give consent. Patients using class Ib antiarrhythmics (lidocaine, mexiletine) due to increased risk of additive toxicity due to structural similarities. (see SPC) Known partial or total heart block that has not had a pacemaker inserted (see SPC) Severe hepatic failure (spontaneous prothrombin time -international normalized ratio (PT-INR)> 2.0). These patients are not offered this type of procedure as day surgery due to the high risk of complications for the surgery itself. Severe renal failure (estimated glomerular filtration rate <15 ml / min / 1.73m2).

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. | Drug: Bupivacaine<br>* Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.<br>* Other names: Marcain;|
| Placebo Comparator: Sodium chloride<br>Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils. | Drug: Sodium chloride<br>* Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.<br>* Other names: Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in self-reported pain at rest. | Difference in self-reported pain at rest by the numerical rating scale (0-10, 0 = no pain, 10 worst pain) for patients aged 10 years and older, and indicated by the faces pain scale-revised (0-10, 0 = no pain, 10 worst pain) for patients aged 5-10 years old, on average over all measurement times. Pain is registered at 1,2,3,4,5 and 6 hours. | Until 6 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain when swallowing on average over all measurement times. | Difference in pain according to the numerical rating scale (0-10, 0 = no pain, 10 worst pain) between the two groups when swallowing on average over all measurement times. Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively. | Until 6 days postoperatively | 
| Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram | Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively | Until 6 days postoperatively | 
| Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 1 after the operation |  | Until 1 day postoperatively | 
| Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 6 after the operation |  | Until 6 days postoperatively | 
| Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 1 after the operation |  | Until 1 day postoperatively | 
| Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 6 after the operation |  | Until 6 days postoperatively | 
| Difference in defined daily doses of morphine in the two groups |  | Until 6 days postoperatively | 
| Difference in number and type a) serious adverse event, b) serious adverse reaction and c) adverse reaction where the adverse reaction is an adverse medical event where there is a probable or possible association with the test preparation |  | Until one hour postoperatively | 
| Difference in hours of nausea |  | Until 6 days postoperatively | 
| Difference in the number of times eaten solid food |  | Until 6 days postoperatively | 
| Number of vomiting episodes |  | Until 6 days postoperatively | 
| Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively |  | Until 6 days postoperatively | 
| Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner |  | Until 6 days postoperatively |