Clinical trial NCT04427904: Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery
Official title: Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Pain
Thyroid Diseases
Anesthesia, Local
Keywords: Thyroidectomy
Bupivacaine
Lidocaine
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 30 minutes after surgery
measure: Postoperative Pain
timeFrame: 1 hour after surgery
measure: Postoperative Pain
timeFrame: 2 hours after surgery
measure: Postoperative Pain
timeFrame: 3 hours after surgery
measure: Postoperative Pain
timeFrame: 4 hours after surgery
measure: Postoperative Pain
timeFrame: 8 hours after surgery
measure: Postoperative Pain
timeFrame: 12 hours after surgery
Secondary outcomes:
measure: First dose of additional postoperative analgesia
timeFrame: Up to 72 hours after surgery
measure: Inpatient analgesia utilization
timeFrame: Up to 72 hours after surgery
measure: Outpatient analgesia utilization
timeFrame: Up to 4 weeks after surgery
measure: Time to return of sensation
timeFrame: Up to 4 weeks after surgery
measure: Incidence of postoperative complications
timeFrame: 4 weeks
measure: Incidence of local anesthesia related adverse events
timeFrame: 4 weeks
measure: Postoperative pain
timeFrame: 1 week
measure: Postoperative pain
timeFrame: 2 week
measure: Postoperative pain
timeFrame: 4 week
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joeseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Hospital Hamilton
name: Han Zhang, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: