Postoperative Analgesia and Recovery Quality in Total Thyroidectomy

April 20, 2026 updated by: İlke Dolgun, Istinye University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Cervical Plexus Block
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Serpil Tiroid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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