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Completed

NCT Number: NCT04825704

Bupivacaine in Tonsillectomy

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nordland Hospital

Bodø, N-8096, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bupivacaine

Drug

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

Other names: Marcain

Sodium Chloride

Drug

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

Other names: Saline

Primary outcomes

  1. Difference in self-reported pain at rest.

    Time frame: Until 6 hours postoperatively.

    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.

Secondary outcomes

  1. Difference in pain when swallowing on average over all measurement times.

    Time frame: Until 6 days postoperatively

    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.

  2. Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram

    Time frame: Until 6 days postoperatively

    Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively

  3. Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 1 after the operation

    Time frame: Until 1 day postoperatively

  4. Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 6 after the operation

    Time frame: Until 6 days postoperatively

  5. Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 1 after the operation

    Time frame: Until 1 day postoperatively

  6. Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 6 after the operation

    Time frame: Until 6 days postoperatively

  7. Difference in defined daily doses of morphine in the two groups

    Time frame: Until 6 days postoperatively

  8. 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

    Time frame: Until one hour postoperatively

  9. Difference in hours of nausea

    Time frame: Until 6 days postoperatively

  10. Difference in the number of times eaten solid food

    Time frame: Until 6 days postoperatively

  11. Number of vomiting episodes

    Time frame: Until 6 days postoperatively

  12. Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively

    Time frame: Until 6 days postoperatively

  13. Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner

    Time frame: Until 6 days postoperatively

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Registry information

Official study title

Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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