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Bupivacaine in Tonsillectomy

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 3

Locations

Norway

Study Type

Interventional

Intervention

Bupivacaine

Sodium chloride

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

5 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Nordland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Sodium chloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

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

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

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

Difference in defined daily doses of morphine in the two groups

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

Difference in hours of nausea

Difference in the number of times eaten solid food

Number of vomiting episodes

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

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

Full Information

NCT ID

NCT04825704

First Posted

March 24, 2021

Last Updated

August 2, 2023

Sponsor

Nordlandssykehuset HF

1. Study Identification

Unique Protocol Identification Number

NCT04825704

Brief Title

Bupivacaine in Tonsillectomy

Official Title

Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 27, 2021 (Actual)

Primary Completion Date

June 27, 2023 (Actual)

Study Completion Date

June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nordlandssykehuset HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sodium chloride

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcain

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sodium chloride

Other Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in self-reported pain at rest.

Description

Time Frame

Until 6 hours postoperatively.

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Until 6 days postoperatively

Title

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

Description

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

Time Frame

Until 6 days postoperatively

Title

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

Title

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

Title

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

Title

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

Title

Difference in defined daily doses of morphine in the two groups

Time Frame

Until 6 days postoperatively

Title

Time Frame

Until one hour postoperatively

Title

Difference in hours of nausea

Time Frame

Until 6 days postoperatively

Title

Difference in the number of times eaten solid food

Time Frame

Until 6 days postoperatively

Title

Number of vomiting episodes

Time Frame

Until 6 days postoperatively

Title

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

Time Frame

Until 6 days postoperatively

Title

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

Time Frame

Until 6 days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin S Berg, MD PhD

Organizational Affiliation

Nordlandssykehuset HF

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Erik W Nielsen, MD PhD

Organizational Affiliation

Nordlandssykehuset HF

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nordland Hospital

City

Bodø

ZIP/Postal Code

N-8096

Country

Norway

12. IPD Sharing Statement

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Bupivacaine in Tonsillectomy

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