AnalgesiaNCT04325113
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics
A study testing levobupivacaine in people with Analgesia, run by University of Liege at 1 site in Belgium.
Trial summary
Check analgesia after tonsillectomy in adults Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- levobupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2019to 15 Jan 2020
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tonsillectomy
Who cannot join
- Gastric or duodenal ulcer
- Diabetes
- Kidney failure
- Chronic pain and fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%
Check analgesia after tonsillectomy in adults
Read the detailed description
We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.
- Conditions
- Analgesia
- Being tested
- levobupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levobupivacaineDrug
Also called xylocaine, Nacl
Patient satisfaction and pain score using a visual anagogic scale (VAS)
| Study group | Role | What they receive |
|---|---|---|
| NaCl 0,9% | Placebo comparator | patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge Receives: Drug: levobupivacaine |
| Xylocaine 2% | Active comparator | patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge Receives: Drug: levobupivacaine |
| Levobupivacaine 0,5% | Active comparator | patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge Receives: Drug: levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction and pain score
patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)
Measured: until 10 days after the tonsillectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start7 Feb 2019
- Primary completion31 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325113
- Sponsor's protocol ID
- Tonsilstopic
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%
- ClinicalTrials.gov ID
- NCT04325113
- Acronym / sponsor ID
- Tonsilstopic
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 27 Mar 2020 (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.
Check analgesia after tonsillectomy in adults
Detailed description
We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NaCl 0,9% | Placebo comparator | Drug: levobupivacainepatients receive 5ml of NaCl 0,9% at the level of the tonsils lodge |
| Xylocaine 2% | Active comparator | Drug: levobupivacainepatients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge |
| Levobupivacaine 0,5% | Active comparator | Drug: levobupivacainepatients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Tonsillectomy
Key exclusion criteria (4 listed)
- Gastric or duodenal ulcer
- Diabetes
- Kidney failure
- Chronic pain and fibromyalgia
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 |
|---|---|---|
| levobupivacaineAlso: xylocaine, NaclPatient satisfaction and pain score using a visual anagogic scale (VAS) | Drug | Levobupivacaine 0,5%, NaCl 0,9%, Xylocaine 2% |
Primary outcome
Patient's satisfaction and pain score
Time frame: until 10 days after the tonsillectomy.
patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain)
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 27 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levobupivacaine in people with Analgesia, run by University of Liege at 1 site in Belgium.
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 4 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 27 Mar 2020. 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 Belgium. 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.
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?
Patient's satisfaction and pain score (time frame: until 10 days after the tonsillectomy.). 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 27 Mar 2020.