Chronic PainPhase 4ThyrobloketNCT07230392
Superficial Cervical Plexus Block Versus Ketamine in the Prevention of Chronic Pain After Thyroidectomy
A Phase 4 study testing Ketamine perfusion and Superficial cervical plexus block in people with Chronic Pain and Thyroidectomy, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Thyroidectomy
- What is being tested?
- Ketamine perfusion and Superficial cervical plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTunisia
- Study dates
- 14 Oct 2024to 5 Jul 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Scheduled for thyroidectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent
Who cannot join
- Known allergy to ketamine or local anesthetics
- Severe renal impairment with estimated Glomerular Filtration Rate (eGFR) under 30 mL/min
- History of neurological disorders
- History of psychiatric illness
- History of severe cardiac disease (NYHA III-IV) or serious arrhythmias
- Pregnancy or breastfeeding
Show all 9Show fewer
- Morbid obesity (BMI > 40 kg/m²)
- Cognitive or communication impairment
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mohamed Taher Maamouri University Hospital
Nabeul, Nabeul Governorate, 8000
About this study
Official title: Comparison of Superficial Cervical Plexus Block and Ketamine in the Prevention of Chronic Pain After Thyroidectomy: Results of a Prospective Randomized Study
The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy
- Conditions
- Chronic Pain, Thyroidectomy
- Being tested
- Ketamine perfusion, Superficial cervical plexus block
- Keywords
- Ketamine, Thyroidectomy, Cervical block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine perfusionDrug
Intravenous ketamine 0.25 mg/kg bolus followed by a 2 µg/kg/min infusion
Superficial cervical plexus blockProcedure or surgery
Bilateral ultrasound-guided superficial cervical plexus block after induction(Ropivacaine 0.2% Ropivacaine 0.2%, with a volume of 10 mL administered to each side) was performed for patients of this group
| Study group | Role | What they receive |
|---|---|---|
| BCS Group | Active comparator | Patients received a bilateral ultrasound-guided superficial cervical plexus block after induction (Ropivacaine 0.2%,with a volume of 10 mL administered to each side) Receives: Procedure: Superficial cervical plexus block |
| KETA group | Active comparator | Patients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion). Receives: Drug: Ketamine perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic neuropathic pain at three months
The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.
Measured: three months after thyroidectomy
Secondary outcomes (5)
Twenty-four hour postoperative rescue analgesia requirements
The total amount of extra, on-demand pain medication a patient needed in the first 24 hours after their surgery was completed.
Measured: within the first 24 hours after the thyroidectomy.
Intraoperative sufentanil consumption
The secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.
Measured: During the intraoperative period
Postoperative sleep quality
Sleep quality was assessed 24 hours postoperatively to accurately reflect the effects of analgesia, utilizing the Athens Insomnia Scale (AIS) score.
Measured: During the first 24 postoperative hours.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery
Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.
Measured: 24 hours after surgery.
The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.
Patients underwent Observer's Assessment of Alertness/Sedation (OAA/S) assessment within a 2-hour timeframe following thyroidectomy, before being cleared for PACU discharge.
Measured: 2-hour timeframe following thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start14 Oct 2024
- Primary completion25 Apr 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Taleb Ibtissem, University Tunis El Manar
- Investigators
- ibtissem BEN TALEB, Principal investigator, University of Tunis El Manar, Anesthesia and critical care department, Taher Maamouri University Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230392
- Sponsor's protocol ID
- Thyrobloket
- Acronym
- Thyrobloket
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Superficial Cervical Plexus Block and Ketamine in the Prevention of Chronic Pain After Thyroidectomy: Results of a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07230392
- Acronym / sponsor ID
- Thyrobloket / Thyrobloket
- Conditions
- Chronic Pain, Thyroidectomy
- Keywords
- Ketamine, Thyroidectomy, Cervical block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 17 Nov 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.
The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCS Group | Active comparator | Procedure: Superficial cervical plexus blockPatients received a bilateral ultrasound-guided superficial cervical plexus block after induction (Ropivacaine 0.2%,with a volume of 10 mL administered to each side) |
| KETA group | Active comparator | Drug: Ketamine perfusionPatients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years
- Scheduled for thyroidectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent
Key exclusion criteria (9 listed)
- Known allergy to ketamine or local anesthetics
- Severe renal impairment with estimated Glomerular Filtration Rate (eGFR) under 30 mL/min
- History of neurological disorders
- History of psychiatric illness
- History of severe cardiac disease (NYHA III-IV) or serious arrhythmias
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 |
|---|---|---|
| Ketamine perfusionIntravenous ketamine 0.25 mg/kg bolus followed by a 2 µg/kg/min infusion | Drug | KETA group |
| Superficial cervical plexus blockBilateral ultrasound-guided superficial cervical plexus block after induction(Ropivacaine 0.2% Ropivacaine 0.2%, with a volume of 10 mL administered to each side) was performed for patients of this group | Procedure or surgery | BCS Group |
Primary outcome
The incidence of chronic neuropathic pain at three months
Time frame: three months after thyroidectomy
The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.
5 secondary outcomes
Twenty-four hour postoperative rescue analgesia requirements
Time frame: within the first 24 hours after the thyroidectomy.
Intraoperative sufentanil consumption
Time frame: During the intraoperative period
Postoperative sleep quality
Time frame: During the first 24 postoperative hours.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery
Time frame: 24 hours after surgery.
The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.
Time frame: 2-hour timeframe following thyroidectomy
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 Nov 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. This study is not recruiting at the moment.
ibtissem BEN TALEB principal investigator
University of Tunis El Manar, Anesthesia and critical care department, Taher Maamouri University Hospital,
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 Ketamine perfusion and Superficial cervical plexus block in people with Chronic Pain and Thyroidectomy, run by University Tunis El Manar at 1 site in Tunisia.
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 9 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 Nov 2025. 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 Tunisia. 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. 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?
The incidence of chronic neuropathic pain at three months (time frame: three months after thyroidectomy). 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 Nov 2025.