Bupivacaine in Tonsillectomy

NCT ID: NCT04825704

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2023-06-27

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Sodium chloride

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

Group Type: PLACEBO_COMPARATOR

Sodium chloride

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

Sodium chloride

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

Intervention Type: DRUG

Other Intervention Names

Marcain; Saline

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordlandssykehuset HF

OTHER

Sponsor Role: lead

Responsible Party

Kristin Sandal Berg, MD PhD

Trainee in anesthesiology, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin S Berg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nordlandssykehuset HF

Erik W Nielsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nordlandssykehuset HF

Locations

Nordland Hospital

Bodø, , Norway

Countries

Norway

Other Identifiers

BupivacTons20

Identifier Type: -

Identifier Source: org_study_id