Comparing Bupivacaine and Lidocaine for Pain Relief After Thyroid Surgery
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
PHASE2 · St. Joseph's Healthcare Hamilton · NCT04427904
This study is testing whether Bupivacaine or Lidocaine works better for pain relief after thyroid surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT04427904 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Bupivacaine versus Lidocaine for managing postoperative pain in patients undergoing total thyroidectomy. Participants will be randomly assigned to receive either Bupivacaine or Lidocaine infiltration at the surgical incision site. The study will utilize a double-blind design to ensure unbiased results, with patients monitored for pain control in the postoperative period. The goal is to determine which anesthetic provides better pain relief after thyroid surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with thyroid disease who are scheduled for total thyroidectomy and can be admitted for at least 12 hours postoperatively.
Not a fit: Patients with advanced thyroid cancer, previous thyroid surgeries, or certain medical histories such as diabetes or chronic pain medication use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing thyroid surgery.
How similar studies have performed: Previous studies have shown varying success in using local anesthetics for postoperative pain management, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- St. Joeseph's Healthcare Hamilton — Hamilton, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Han Zhang, MD FRCSC — St. Joseph's Hospital Hamilton
- Study coordinator: Michael Xie, MD
- Email: michael.xie@medportal.ca
- Phone: (905) 522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain, Thyroid Diseases, Anesthesia, Local, Thyroidectomy, Bupivacaine, Lidocaine