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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
|
| Lidocaine | Active Comparator | Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 0.5% with 1:200 000 epinephrine | Drug | Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| First dose of additional postoperative analgesia | Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered | Up to 72 hours after surgery |
| Inpatient analgesia utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Xie, MD | Contact | (905) 522-1155 | 4765 | michael.xie@medportal.ca |
| Han Zhang, MD FRCSC | Contact | (905) 521-2100 | 37031 | hanzhang@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Han Zhang, MD FRCSC | St. Joseph's Hospital Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joeseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N4A6 | Canada |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Lidocaine 2% with 1:100 000 epinephrine | Drug | Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
|
|
| 8 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 | 12 hours after surgery |
Quantity of standardized analgesia used during admission
| Up to 72 hours after surgery |
| Outpatient analgesia utilization | Quantity of standardized analgesia used between discharge and 4 week outpatient follow up | Up to 4 weeks after surgery |
| Time to return of sensation | Patient reported time to return of sensation at surgical site | Up to 4 weeks after surgery |
| Incidence of postoperative complications | Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia | 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. | 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 | 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 | 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 | 4 week |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D000588 |
| Amines |
| D000083 | Acetanilides |