Postoperative PainNCT07547124
Postoperative Analgesia and Recovery Quality in Total Thyroidectomy
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates the association between postoperative analgesic approaches and recovery outcomes in patients undergoing elective total thyroidectomy. Patients will be followed under routine clinical care without intervention or randomization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Cervical Plexus Block
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 10 Sep 2026
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-75 years with ASA physical status I-III scheduled for elective bilateral total thyroidectomy under general anesthesia. Participants must be cognitively able to read Turkish and complete the QoR-15 questionnaire and provide written informed consent. Patients with chronic opioid use, chronic pain syndromes, psychiatric or neurological disorders, previous cervical surgery, planned extensive surgery, emergency procedures, pregnancy, or expected postoperative ICU need are excluded.
Who may be able to join
- Patients aged 18-75 years
- ASA physical status classification I-III
- Patients scheduled for elective bilateral total thyroidectomy
- Patients undergoing surgery under general anesthesia
- Individuals able to read and understand Turkish and cognitively capable of completing the QoR-15 questionnaire
- Patients providing written informed consent to participate in the study
Who cannot join
- Chronic opioid use (≥3 months of regular opioid use)
- Presence of chronic pain syndrome
- Psychiatric illness or cognitive impairment
- History of neurological disease (stroke, dementia, Parkinson's disease, etc.)
- Known allergy to local anesthetic agents
- Previous surgical interventions in the cervical region (including revision thyroid surgery)
Show all 13Show fewer
- Planned extended surgery with concomitant neck dissection
- Substernal/retrosternal goiter cases (with potential need for sternotomy or additional procedures)
- Emergency surgical procedures
- Patients with ASA physical status IV or higher
- Pregnancy
- Patients expected to require postoperative intensive care
- Patients experiencing intraoperative complications that deviate from the standard monitoring protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Association Between Postoperative Analgesic Approaches and Quality of Recovery and Swallowing Pain in Patients Undergoing Elective Total Thyroidectomy: A Prospective Observational Study
This prospective observational study evaluates the association between postoperative analgesic approaches and recovery outcomes in patients undergoing elective total thyroidectomy. Patients will be followed under routine clinical care without intervention or randomization.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include swallowing pain, resting pain, opioid consumption, postoperative nausea and vomiting, and additional analgesic requirement.
- Conditions
- Postoperative Pain
- Being tested
- Cervical Plexus Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Plexus BlockOther
Bilateral intermediate cervical plexus block may be performed as part of routine clinical practice based on the attending anesthesiologist's decision. The study is observational, and no intervention, assignment, or protocol-driven procedure is applied. Patients are managed according to standard perioperative care.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Plexus Block Group | Patients who receive bilateral intermediate cervical plexus block as part of routine clinical practice, based on the attending anesthesiologist's decision. | |
| No Block Group | Patients who do not receive cervical plexus block and are managed with standard postoperative analgesia according to routine clinical practice. Receives: Other: Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) Total Score
Quality of recovery will be assessed using the QoR-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome will be compared between patients who received cervical plexus block and those who did not.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547124
- Sponsor's protocol ID
- Serpil Tiroid
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wilson L, Malhotra R, Mayhew D, Banerjee A. The analgesic effects of bilateral superficial cervical plexus block in thyroid surgery: A systematic review and meta-analysis. Indian J Anaesth. 2023 Jul;67(7):579-589. doi: 10.4103/ija.ija_806_22. Epub 2023 Jul 14.
PubMed 37601928Mostafa MM, Gamal RM, Ahmed Baiomy AM, Hassan ME, Kamal JM, Ts T, Kotb TA, Elrawas MM. Efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided intermediate cervical plexus block for thyroidectomy surgery: randomized controlled study. BMC Anesthesiol. 2025 Mar 25;25(1):139. doi: 10.1186/s12871-025-02990-7.
PubMed 40133795
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postoperative Analgesic Approaches and Quality of Recovery and Swallowing Pain in Patients Undergoing Elective Total Thyroidectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07547124
- Acronym / sponsor ID
- Serpil Tiroid
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
This prospective observational study evaluates the association between postoperative analgesic approaches and recovery outcomes in patients undergoing elective total thyroidectomy. Patients will be followed under routine clinical care without intervention or randomization.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include swallowing pain, resting pain, opioid consumption, postoperative nausea and vomiting, and additional analgesic requirement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Plexus Block Group | – | –Patients who receive bilateral intermediate cervical plexus block as part of routine clinical practice, based on the attending anesthesiologist's decision. |
| No Block Group | – | Other: Cervical Plexus BlockPatients who do not receive cervical plexus block and are managed with standard postoperative analgesia according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-75 years with ASA physical status I-III scheduled for elective bilateral total thyroidectomy under general anesthesia. Participants must be cognitively able to read Turkish and complete the QoR-15 questionnaire and provide written informed consent. Patients with chronic opioid use, chronic pain syndromes, psychiatric or neurological disorders, previous cervical surgery, planned extensive surgery, emergency procedures, pregnancy, or expected postoperative ICU need are excluded.
Key inclusion criteria (6 listed)
- Patients aged 18-75 years
- ASA physical status classification I-III
- Patients scheduled for elective bilateral total thyroidectomy
- Patients undergoing surgery under general anesthesia
- Individuals able to read and understand Turkish and cognitively capable of completing the QoR-15 questionnaire
Key exclusion criteria (13 listed)
- Chronic opioid use (≥3 months of regular opioid use)
- Presence of chronic pain syndrome
- Psychiatric illness or cognitive impairment
- History of neurological disease (stroke, dementia, Parkinson's disease, etc.)
- Known allergy to local anesthetic agents
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 |
|---|---|---|
| Cervical Plexus BlockBilateral intermediate cervical plexus block may be performed as part of routine clinical practice based on the attending anesthesiologist's decision. The study is observational, and no intervention, assignment, or protocol-driven procedure is applied. Patients are managed according to standard perioperative care. | Other | No Block Group |
Primary outcome
Quality of Recovery-15 (QoR-15) Total Score
Time frame: 24 hours postoperatively
Quality of recovery will be assessed using the QoR-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome will be compared between patients who received cervical plexus block and those who did not.
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 Apr 2026.
- Results publication: PubMed 37601928Wilson L, Malhotra R, Mayhew D, Banerjee A. The analgesic effects of bilateral superficial cervical plexus block in thyroid surgery: A systematic review and meta-analysis. Indian J Anaesth. 2023 Jul;67(7):579-589. doi: 10.4103/ija.ija_806_22. Epub 2023 Jul 14.
- Results publication: PubMed 40133795Mostafa MM, Gamal RM, Ahmed Baiomy AM, Hassan ME, Kamal JM, Ts T, Kotb TA, Elrawas MM. Efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided intermediate cervical plexus block for thyroidectomy surgery: randomized controlled study. BMC Anesthesiol. 2025 Mar 25;25(1):139. doi: 10.1186/s12871-025-02990-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
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 6 inclusion and 13 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 Apr 2026. 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 Turkey (Türkiye). 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.
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 İlke Dolgun (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) Total Score (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07547124, which also lists 2 linked publications.
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 Apr 2026.