Clinical trial NCT04825704: Bupivacaine in Tonsillectomy
Official title: Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years

Exclusion Criteria:

1. Known allergy to local anesthetics.
2. 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.
3. Persons weighing less than 10 kg.
4. Persons over the age of 18 who are not competent to give consent.
5. Patients using class Ib antiarrhythmics (lidocaine, mexiletine) due to increased risk of additive toxicity due to structural similarities. (see SPC)
6. Known partial or total heart block that has not had a pacemaker inserted (see SPC)
7. 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.
8. Severe renal failure (estimated glomerular filtration rate \<15 ml / min / 1.73m2).

Primary outcomes:
measure: Difference in self-reported pain at rest.
timeFrame: Until 6 hours postoperatively.
Secondary outcomes:
measure: Difference in pain when swallowing on average over all measurement times.
timeFrame: Until 6 days postoperatively
measure: Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram
timeFrame: Until 6 days postoperatively
measure: Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 1 after the operation
timeFrame: Until 1 day postoperatively
measure: Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 6 after the operation
timeFrame: Until 6 days postoperatively
measure: Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 1 after the operation
timeFrame: Until 1 day postoperatively
measure: Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 6 after the operation
timeFrame: Until 6 days postoperatively
measure: Difference in defined daily doses of morphine in the two groups
timeFrame: Until 6 days postoperatively
measure: 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
timeFrame: Until one hour postoperatively
measure: Difference in hours of nausea
timeFrame: Until 6 days postoperatively
measure: Difference in the number of times eaten solid food
timeFrame: Until 6 days postoperatively
measure: Number of vomiting episodes
timeFrame: Until 6 days postoperatively
measure: Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively
timeFrame: Until 6 days postoperatively
measure: Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner
timeFrame: Until 6 days postoperatively
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordland Hospital
Study officials:
affiliation: Nordlandssykehuset HF
name: Kristin S Berg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nordlandssykehuset HF
name: Erik W Nielsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: