NCT07547124

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

April 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 2, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours postoperatively

Study Arms (2)

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

Interventions

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.

No Block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 23, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations