Pain, PostoperativePhase 3NCT04825704
Bupivacaine in Tonsillectomy
A Phase 3 study testing Bupivacaine and Sodium chloride in people with Pain, Postoperative, run by Nordlandssykehuset HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine and Sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteNorway
- Study dates
- 27 Oct 2021to 27 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine, Sodium chloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcain
Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
Sodium chlorideDrug
Also called Saline
Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. Receives: 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. Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 6 hours postoperatively.
Secondary outcomes (13)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Until 6 days postoperatively
Difference in defined daily doses of morphine in the two groups
Measured: 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
Measured: Until one hour postoperatively
Difference in hours of nausea
Measured: Until 6 days postoperatively
Difference in the number of times eaten solid food
Measured: Until 6 days postoperatively
Number of vomiting episodes
Measured: Until 6 days postoperatively
Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively
Measured: Until 6 days postoperatively
Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner
Measured: Until 6 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start27 Oct 2021
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Sandal Berg, MD PhD, Nordlandssykehuset HF
- Investigators
- Kristin S Berg, MD PhD, Principal investigator, Nordlandssykehuset HFErik W Nielsen, MD PhD, Principal investigator, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825704
- Sponsor's protocol ID
- BupivacTons20
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?
- ClinicalTrials.gov ID
- NCT04825704
- Acronym / sponsor ID
- BupivacTons20
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: BupivacaineTopical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. |
| Sodium chloride | Placebo comparator | Drug: Sodium chlorideTopical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: MarcainTopical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. | Drug | Bupivacaine |
| Sodium chlorideAlso: SalineTopical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils. | Drug | Sodium chloride |
Primary outcome
Difference in self-reported pain at rest.
Time frame: 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.
13 secondary outcomes
Difference in pain when swallowing on average over all measurement times.
Time frame: Until 6 days postoperatively
Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Until 6 days postoperatively
Difference in defined daily doses of morphine in the two groups
Time frame: 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
Time frame: Until one hour postoperatively
Difference in hours of nausea
Time frame: Until 6 days postoperatively
Difference in the number of times eaten solid food
Time frame: Until 6 days postoperatively
Number of vomiting episodes
Time frame: Until 6 days postoperatively
Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively
Time frame: Until 6 days postoperatively
Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner
Time frame: Until 6 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin S Berg, MD PhD principal investigator
Nordlandssykehuset HF
Erik W Nielsen, MD PhD principal investigator
Nordlandssykehuset HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and Sodium chloride in people with Pain, Postoperative, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in self-reported pain at rest. (time frame: Until 6 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.