Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Diseases; Postoperative Pain; Anesthesia, Local
• Intervention / Treatment: Drug: Bupivacaine 0.5% with 1:200 000 epinephrine; Drug: Lidocaine 2% with 1:100 000 epinephrine

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).

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Xie, MD; Phone Number: 4765 (905) 522-1155; Email: michael.xie@medportal.ca
• Study Contact Backup: Name: Han Zhang, MD FRCSC; Phone Number: 37031 (905) 521-2100; Email: hanzhang@stjosham.on.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • Recruiting
      • St. Joeseph's Healthcare Hamilton
      • Contact: Michael Xie, MD; Phone Number: 4765 (905) 522-1155; Email: michael.xie@medportal.ca
      • Contact: Han Zhang, MD FRCSC; Phone Number: 37031 (905) 521-2100; Email: hanzhang@stjosham.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Han Zhang, MD FRCSC, St. Joseph's Hospital Hamilton

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lidocaine; Bupivacaine; Thyroidectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Endocrine System Diseases; Pain, Postoperative; Thyroid Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 7336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No