Recruiting
Phase 2

Bupivacaine vs. Lidocaine

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04427904

Conditions

Postoperative Pain

Thyroid Diseases

Anesthesia, Local

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine 0.5% with 1:200 000 epinephrine

Lidocaine 2% with 1:100 000 epinephrine

Study Details

Brief summary:

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

Conditions

Postoperative Pain

Thyroid Diseases

Anesthesia, Local

Study ID

NCT04427904

Start date

Jun 1, 2022

Status verified date

Nov, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bupivacaine

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

active comparator: Lidocaine

Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Interventions

Bupivacaine 0.5% with 1:200 000 epinephrine

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Lidocaine 2% with 1:100 000 epinephrine

Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Primary outcome measure

  • Postoperative Pain [ Time Frame: 30 minutes after surgery ]
  • Postoperative Pain [ Time Frame: 1 hour after surgery ]
  • Postoperative Pain [ Time Frame: 2 hours after surgery ]
  • Postoperative Pain [ Time Frame: 3 hours after surgery ]
  • Postoperative Pain [ Time Frame: 4 hours after surgery ]
  • Postoperative Pain [ Time Frame: 8 hours after surgery ]
  • Postoperative Pain [ Time Frame: 12 hours after surgery ]

Central Contacts and Locations

Central contacts

Michael Xie, MD

(905) 522-1155michael.xie@medportal.ca

Han Zhang, MD FRCSC

(905) 521-2100hanzhang@stjosham.on.ca

Locations

St. Joeseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N4A6

Contacts

Michael Xie, MD

(905) 522-1155michael.xie@medportal.ca

Han Zhang, MD FRCSC

(905) 521-2100hanzhang@stjosham.on.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Keywords

  • Thyroidectomy
  • Bupivacaine
  • Lidocaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2023-11-28.