Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

St. Joseph's Healthcare Hamilton

Status and phase: Enrolling; Phase 2

Conditions: Thyroid Diseases; Postoperative Pain; Anesthesia, Local

Treatments: Drug: Bupivacaine 0.5% with 1:200 000 epinephrine; Drug: Lidocaine 2% with 1:100 000 epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04427904

7336

Details and patient eligibility

About

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

Full description

Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups

Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine 0.5% with 1:200 000 epinephrine

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine 2% with 1:100 000 epinephrine