Anesthesia, Local, Postoperative Pain, Thyroid Diseases
Conditions
Keywords
Thyroidectomy, Bupivacaine, Lidocaine
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).
Interventions
DRUGBupivacaine 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. Total volume 10mL for local infiltration before neck incision.
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 30 minutes after surgery | Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient analgesia utilization | Up to 72 hours after surgery | Quantity of standardized analgesia used during admission |
| Outpatient analgesia utilization | Up to 4 weeks after surgery | Quantity of standardized analgesia used between discharge and 4 week outpatient follow up |
| Time to return of sensation | Up to 4 weeks after surgery | Patient reported time to return of sensation at surgical site |
| First dose of additional postoperative analgesia | Up to 72 hours after surgery | Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered |
| Incidence of local anesthesia related adverse events | 4 weeks | Incidence of adverse events including CNS (tinnitus, blurred vision, dizziness, tongue paresthesias, circumoral numbness, seizures, CNS depression) and cardiovascular (hear block, sinus bradycardia, sinus arrest, ventricular arrhythmias) events. |
| Postoperative pain | 1 week | Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome |
| Incidence of postoperative complications | 4 weeks | Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia |
Countries
Canada
Contacts
Primary ContactMichael Xie, MD
Backup ContactHan Zhang, MD FRCSC
Outcome results
None listed