- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547124
Postoperative Analgesia and Recovery Quality in Total Thyroidectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: İlke Dolgun
- Phone Number: 05555485632
- Email: ilkeser2004@gmail.com
Study Locations
-
-
Merkez Mahallesi
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Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Mostafa 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Serpil Tiroid
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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