Thyroid SurgeryPhase 3NCT06789575
Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery
A Phase 3 study testing Bupivacaine, Adrenaline and Lidocaine (drug) in people with Thyroid Surgery, run by Assiut University.
Trial summary
Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Bupivacaine, Adrenaline and Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal thyroid function patients of both genders scheduled for thyroid surgery will included in this study
- If they are over the age of 18
- If they had an ASA score (American Society of Anesthesiology) I, II.
- A Score of Mallampati I , II.
Who cannot join
- Patient refused to participate in the study.
- Patients will be excluded if they have any analgesic medication or corticosteroid drug prior surgery or
- A known or suspected allergy to local anesthetics,
- if the duration of surgery is greater than 5 h and if a major complication of surgery or anesthesia (major bleeding, allergy to anesthetic products).
- Patients who have lateral neck dissection associated with Thyroid surgery are excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed Hussien Abdel hakim Mohamed, residant doctor contact
About this study
Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.
the aim of the study to evaluate the effects of bupivacaine instillation after thyroidectomy against infiltration into the surgical field in order to reduce postoperative discomfort following thyroid surgery.
Read the detailed description
Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.
- Conditions
- Thyroid Surgery
- Being tested
- Bupivacaine, Adrenaline, Lidocaine (drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
the patients will receive the content of a syringe (10 ml of bupivacaine 0.25%)
AdrenalineDrug
the patients will receive the content of a syringe 15 μg adrenaline
Lidocaine (drug)Drug
the patients will receive the content of a syringe 70 ml Lidocaine .
| Study group | Role | What they receive |
|---|---|---|
| Group S | Active comparator | mixture will instilled over the incision before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ). Receives: Drug: Bupivacaine; Drug: Adrenaline; Drug: Lidocaine (drug) |
| Group F | Active comparator | will recieve the mixture by injection inside the wound before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ). Receives: Drug: Bupivacaine; Drug: Adrenaline; Drug: Lidocaine (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic consumption
Total analgesic consumption at 1st. 24 hours postoperative
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hussin Abd elhakim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789575
- Sponsor's protocol ID
- Wound Infilt/InstThyroid Surg
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06789575
- Acronym / sponsor ID
- Wound Infilt/InstThyroid Surg
- Conditions
- Thyroid Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Jan 2025 (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.
Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.
the aim of the study to evaluate the effects of bupivacaine instillation after thyroidectomy against infiltration into the surgical field in order to reduce postoperative discomfort following thyroid surgery.
Detailed description
Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.
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 |
|---|---|---|
| Group S | Active comparator | Drug: Bupivacaine, Drug: Adrenaline, Drug: Lidocaine (drug)mixture will instilled over the incision before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ). |
| Group F | Active comparator | Drug: Bupivacaine, Drug: Adrenaline, Drug: Lidocaine (drug)will recieve the mixture by injection inside the wound before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal thyroid function patients of both genders scheduled for thyroid surgery will included in this study
- If they are over the age of 18
- If they had an ASA score (American Society of Anesthesiology) I, II.
- A Score of Mallampati I , II.
Key exclusion criteria (5 listed)
- Patient refused to participate in the study.
- Patients will be excluded if they have any analgesic medication or corticosteroid drug prior surgery or
- A known or suspected allergy to local anesthetics,
- if the duration of surgery is greater than 5 h and if a major complication of surgery or anesthesia (major bleeding, allergy to anesthetic products).
- Patients who have lateral neck dissection associated with Thyroid surgery are excluded.
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 |
|---|---|---|
| Bupivacainethe patients will receive the content of a syringe (10 ml of bupivacaine 0.25%) | Drug | Group F, Group S |
| Adrenalinethe patients will receive the content of a syringe 15 μg adrenaline | Drug | Group F, Group S |
| Lidocaine (drug)the patients will receive the content of a syringe 70 ml Lidocaine . | Drug | Group F, Group S |
Primary outcome
Total analgesic consumption
Time frame: 24 hours
Total analgesic consumption at 1st. 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Hussien Abdel hakim Mohamed, residant doctor contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine, Adrenaline and Lidocaine (drug) in people with Thyroid Surgery, run by Assiut University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hussien Abdel hakim Mohamed, residant doctor (+201011854982, Ahmed.16266082@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total analgesic consumption (time frame: 24 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 23 Jan 2025.