Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04427904
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)
* Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)
* Will be admitted for at least 12h postoperatively
Exclusion Criteria:
* Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy
* Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)
* Previous ipsilateral thyroid surgery to operation side
* Previous total thyroidectomy or completion thyroidectomy
* History of neck radiation therapy
* Neck dissection beyond central neck (levels 1-5)
* Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy
* Surgery requiring extension of incision beyond 8 cm
* History of diabetes mellitus
* History of renal or liver disease
* History of narcotic abuse
* History of chronic pain medications use in past 6 months for any condition
* History of coagulation defect
* Allergy to Bupivacaine or Lidocaine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04427904
Study Brief:
Protocol Section:
NCT04427904