Status:
COMPLETED
Bupivacaine in Tonsillectomy
Lead Sponsor:
Nordlandssykehuset HF
Conditions:
Pain, Postoperative
Eligibility:
All Genders
5-40 years
Phase:
PHASE3
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 bupi...
Eligibility Criteria
Inclusion
- All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years
Exclusion
- 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).
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04825704
Start Date
October 27 2021
End Date
June 27 2023
Last Update
August 4 2023
Active Locations (1)
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1
Nordland Hospital
Bodø, Norway, N-8096