Bupivacaine in Tonsillectomy

NCT04825704 | Completed Phase 3

• 1 other identifier: BupivacTons20
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in self-reported pain at rest.

  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.

  Until 6 hours postoperatively.

Secondary Outcomes (13)

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

  Until 6 days postoperatively

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

  Until 6 days postoperatively

• 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

• 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

• 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

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Sodium chloride

PLACEBO COMPARATOR

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

Drug: Sodium chloride

Interventions

Bupivacaine DRUG

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

Also known as: Marcain

Bupivacaine

Sodium chloride DRUG

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

Also known as: Saline

Sodium chloride

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years

You may not qualify if:

• Known allergy to local anesthetics.
• 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).

Sponsors & Collaborators

• Nordlandssykehuset HF: lead

Study Sites (1)

Nordland Hospital

Bodø, N-8096, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kristin S Berg, MD PhD

  Nordlandssykehuset HF

  PRINCIPAL INVESTIGATOR

• Erik W Nielsen, MD PhD

  Nordlandssykehuset HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee in anesthesiology, associate professor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: October 27, 2021
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

NO (1)