Bupivacaine in Tonsillectomy

Sponsor
Nordlandssykehuset HF (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04825704
Collaborator
(none)
80
1
2
13.1
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?
Actual Study Start Date :
Oct 27, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine

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

Drug: Bupivacaine
Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
Other Names:
  • Marcain
  • Placebo Comparator: Sodium chloride

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

    Drug: Sodium chloride
    Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
    Other Names:
  • Saline
  • Outcome Measures

    Primary Outcome Measures

    1. Difference in self-reported pain at rest. [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 Outcome Measures

    1. Difference in pain when swallowing on average over all measurement times. [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 [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 [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 [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 [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 [Until 6 days postoperatively]

    7. Difference in defined daily doses of morphine in the two groups [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 [Until one hour postoperatively]

    9. Difference in hours of nausea [Until 6 days postoperatively]

    10. Difference in the number of times eaten solid food [Until 6 days postoperatively]

    11. Number of vomiting episodes [Until 6 days postoperatively]

    12. Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively [Until 6 days postoperatively]

    13. Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner [Until 6 days postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nordland Hospital Bodø Norway N-8096

    Sponsors and Collaborators

    • Nordlandssykehuset HF

    Investigators

    • Principal Investigator: Kristin S Berg, MD PhD, Nordlandssykehuset HF
    • Principal Investigator: Erik W Nielsen, MD PhD, Nordlandssykehuset HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristin Sandal Berg, MD PhD, Trainee in anesthesiology, associate professor, Nordlandssykehuset HF
    ClinicalTrials.gov Identifier:
    NCT04825704
    Other Study ID Numbers:
    • BupivacTons20
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 29, 2021