Bupivacaine in Tonsillectomy

Nordlandssykehuset HF

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Sodium chloride; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04825704

BupivacTons20

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 5 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Bupivacaine

Active Comparator group

Description:

Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.

Treatment:

Drug: Bupivacaine

Sodium chloride

Placebo Comparator group

Description:

Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.

Treatment:

Drug: Sodium chloride