Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial

Conditions
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Postoperative Pain, Thyroid Diseases, Anesthesia, Local

Intervention / Treatment
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* Drug: Bupivacaine 0.5% with 1:200 000 epinephrine
* Drug: Lidocaine 2% with 1:100 000 epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine<br>Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. | Drug: Bupivacaine 0.5% with 1:200 000 epinephrine<br>* Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.<br>* Other names: Marcaine;|
| Active Comparator: Lidocaine<br>Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. | Drug: Lidocaine 2% with 1:100 000 epinephrine<br>* Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.<br>* Other names: Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Bupivacaine, Lidocaine