Thyroid DiseasesPhase 4NCT05294393
Ropivacaine Plus Magnesium Sulphate Infiltration
A Phase 4 study testing Ropivacaine 10% and Ropivacaine 10% plus magnesium sulphate 10mg/kg in people with Thyroid Diseases and Parathyroid Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Diseases, Parathyroid Diseases, Postoperative Pain
- What is being tested?
- Ropivacaine 10% and Ropivacaine 10% plus magnesium sulphate 10mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteGreece
- Study dates
- 19 Jan 2022to 18 Jan 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old
- Surgical indication for Total thyroidectomy
- Surgical indication forparathyroidectomy
Who cannot join
- Patients < 18 years old
- Prior neck operation
- Lateral neck dissection
- Patient with history of chronic opioid use
- Patient with chronic pain syndromes
- Patient with allergy to ropivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication.
Surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia.
It becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery.
- Being tested
- Placebo Comparator: N/S 0.9%, Ropivacaine 10%, Ropivacaine 10% plus magnesium sulphate 10mg/kg
- Keywords
- thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate
- Medical subject headings
- Thyroid Diseases, Parathyroid Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: N/S 0.9%Drug
12 ml N/S 0.9% at the end of surgery
Ropivacaine 10%Drug
12 ml solution of 100mg ropivacaine at the end of surgery
Ropivacaine 10% plus magnesium sulphate 10mg/kgDrug
12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| N/S 0.9% | Placebo comparator | Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure Receives: Drug: Placebo Comparator: N/S 0.9% |
| Ropivacaine 10% | Active comparator | Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure Receives: Drug: Ropivacaine 10% |
| Ropivacaine 10% magnesium sulphate 10mg/kg | Experimental | Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure Receives: Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.
Measured: 24 postoperative hours
Secondary outcomes (5)
Incisional Pain
Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire
Measured: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Subjective measurements 1
Alterations in cortisol in μg/dl
Measured: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 2
Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml
Measured: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 3
Alterations in Interleukin 6 (IL-6) in pg/ml
Measured: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Complications
Adverse effects of the infiltrated agents
Measured: 24 hours, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start19 Jan 2022
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Styliani Konstantinos Laskou, Aristotle University Of Thessaloniki
- Investigators
- Styliani K Laskou, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294393
- Sponsor's protocol ID
- 3.468
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
- ClinicalTrials.gov ID
- NCT05294393
- Acronym / sponsor ID
- 3.468
- Keywords
- thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 24 Mar 2022 (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.
In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication.
Surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia.
It becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N/S 0.9% | Placebo comparator | Drug: Placebo Comparator: N/S 0.9%Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure |
| Ropivacaine 10% | Active comparator | Drug: Ropivacaine 10%Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure |
| Ropivacaine 10% magnesium sulphate 10mg/kg | Experimental | Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kgWound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥ 18 years old
- Surgical indication for Total thyroidectomy
- Surgical indication forparathyroidectomy
Key exclusion criteria (6 listed)
- Patients < 18 years old
- Prior neck operation
- Lateral neck dissection
- Patient with history of chronic opioid use
- Patient with chronic pain syndromes
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 |
|---|---|---|
| Placebo Comparator: N/S 0.9%12 ml N/S 0.9% at the end of surgery | Drug | N/S 0.9% |
| Ropivacaine 10%12 ml solution of 100mg ropivacaine at the end of surgery | Drug | Ropivacaine 10% |
| Ropivacaine 10% plus magnesium sulphate 10mg/kg12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery | Drug | Ropivacaine 10% magnesium sulphate 10mg/kg |
Primary outcome
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
Time frame: 24 postoperative hours
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.
5 secondary outcomes
Incisional Pain
Time frame: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Subjective measurements 1
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 2
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 3
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Complications
Time frame: 24 hours, 7 days
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 17 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Styliani K Laskou principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 10% and Ropivacaine 10% plus magnesium sulphate 10mg/kg in people with Thyroid Diseases and Parathyroid Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 6 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 17 Jul 2024. 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 Greece. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine (time frame: 24 postoperative hours). 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 17 Jul 2024.