Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial

7336

The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.

2022-06-01

2024-12-31

2025-12-31

Recruiting

Early phase I

210

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 210, 'type': 'ESTIMATED'}}

2023-11-28