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Local Anesthetic

Local Anesthetics for Postoperative Pain in Thyroid Surgery

Phase 2
Recruiting
Led By Han Zhang, MD FRCSC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
History of neck radiation therapy
Neck dissection beyond central neck (levels 1-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours after surgery
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial will compare the effects of two different types of medication on post-operative pain control following thyroid surgery.

Who is the study for?
This trial is for individuals with certain types of thyroid disease who are planning to undergo thyroid surgery and can stay in the hospital for at least 12 hours post-surgery. It's not suitable for those with a history of diabetes, narcotic abuse, chronic pain medication use, neck radiation therapy, coagulation defects, allergies to Bupivacaine or Lidocaine, advanced thyroid cancer stages or extensive previous surgeries.
What is being tested?
The study aims to compare the effectiveness of two local anesthetics—Bupivacaine and Lidocaine—for managing postoperative pain after thyroid surgery. Participants will receive one of these drugs during their procedure to see which one provides better pain relief.
What are the potential side effects?
Possible side effects from Bupivacaine or Lidocaine may include numbness around the injection site, mild dizziness, nausea or vomiting. Rarely they might cause allergic reactions like itching or swelling. Serious complications are uncommon but can involve heart or nervous system issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for thyroid surgery involving a cut in the middle of my neck.
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I will stay in the hospital for at least 12 hours after surgery.
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I have been diagnosed with thyroid disease, either a small to medium tumor or benign condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my neck.
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I have had surgery to remove lymph nodes in my neck beyond the central area.
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My goiter extends into my chest or needs surgery to open my chest.
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I have a history of diabetes.
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My thyroid cancer is advanced and may require surgery to open my chest.
Select...
My surgery needed a cut larger than 8 cm.
Select...
I have a history of blood clotting issues.
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My thyroid cancer has spread to neck nodes beyond the thyroid.
Select...
I have had my entire thyroid removed.
Select...
I have had thyroid surgery on the same side before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative Pain
Secondary study objectives
First dose of additional postoperative analgesia
Incidence of local anesthesia related adverse events
Incidence of postoperative complications
+4 more

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BupivacaineExperimental Treatment1 Intervention
Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Group II: LidocaineActive Control1 Intervention
Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
202 Previous Clinical Trials
26,715 Total Patients Enrolled
Han Zhang, MD FRCSCPrincipal InvestigatorSt. Joseph's Hospital Hamilton

Media Library

Bupivacaine 0.5% with 1:200 000 epinephrine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04427904 — Phase 2
Thyroid Disease Research Study Groups: Bupivacaine, Lidocaine
Thyroid Disease Clinical Trial 2023: Bupivacaine 0.5% with 1:200 000 epinephrine Highlights & Side Effects. Trial Name: NCT04427904 — Phase 2
Bupivacaine 0.5% with 1:200 000 epinephrine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04427904 — Phase 2
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