Bupivacaine in Tonsillectomy

Can Topical Administration of Bupivacaine Reduce Pain After 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacaine; Drug: Sodium chloride

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Bodø, Norway, N-8096
    • Nordland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pain when swallowing on average over all measurement times.	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.	Until 6 days postoperatively
Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram	Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively	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
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
Difference in defined daily doses of morphine in the two groups		Until 6 days postoperatively
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
Difference in hours of nausea		Until 6 days postoperatively
Difference in the number of times eaten solid food		Until 6 days postoperatively
Number of vomiting episodes		Until 6 days postoperatively
Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively		Until 6 days postoperatively
Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner		Until 6 days postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: BupivacTons20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No