Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours after surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for thyroid surgery involving a cut in the middle of my neck.
Select...
I will stay in the hospital for at least 12 hours after surgery.
Select...
I have been diagnosed with thyroid disease, either a small to medium tumor or benign condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative Pain
Secondary outcome measures
First dose of additional postoperative analgesia
Incidence of local anesthesia related adverse events
Incidence of postoperative complications
+4 moreTrial 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
197 Previous Clinical Trials
26,238 Total Patients Enrolled
Han Zhang, MD FRCSCPrincipal InvestigatorSt. Joseph's Hospital Hamilton
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had kidney or liver disease in the past.I have had radiation therapy to my neck.I have had surgery to remove lymph nodes in my neck beyond the central area.I am scheduled for thyroid surgery involving a cut in the middle of my neck.You have taken pain medications regularly for any reason in the past 6 months.My goiter extends into my chest or needs surgery to open my chest.I will stay in the hospital for at least 12 hours after surgery.I have a history of diabetes.My thyroid cancer is advanced and may require surgery to open my chest.You have a history of using narcotics in a way that is not prescribed by a doctor.My surgery needed a cut larger than 8 cm.I have a history of blood clotting issues.I have been diagnosed with thyroid disease, either a small to medium tumor or benign condition.My thyroid cancer has spread to neck nodes beyond the thyroid.I have had my entire thyroid removed.I have had thyroid surgery on the same side before.You are allergic to bupivacaine or lidocaine.
Research Study Groups:
This trial has the following groups:- Group 1: Bupivacaine
- Group 2: Lidocaine
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger