The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
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.
St. Joeseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITINGPostoperative Pain
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
Time frame: 30 minutes after surgery
Postoperative Pain
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
Time frame: 1 hour after surgery
Postoperative Pain
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
Time frame: 2 hours after surgery
Postoperative Pain
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
Time frame: 3 hours after surgery
Postoperative Pain
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
Time frame: 4 hours after surgery
Postoperative Pain
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
Time frame: 8 hours after surgery
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Postoperative Pain
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
Time frame: 12 hours after surgery
First dose of additional postoperative analgesia
Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered
Time frame: Up to 72 hours after surgery
Inpatient analgesia utilization
Quantity of standardized analgesia used during admission
Time frame: Up to 72 hours after surgery
Outpatient analgesia utilization
Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
Time frame: Up to 4 weeks after surgery
Time to return of sensation
Patient reported time to return of sensation at surgical site
Time frame: Up to 4 weeks after surgery
Incidence of postoperative complications
Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
Time frame: 4 weeks
Incidence of local anesthesia related adverse events
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.
Time frame: 4 weeks
Postoperative pain
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
Time frame: 1 week
Postoperative pain
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
Time frame: 2 week
Postoperative pain
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
Time frame: 4 week