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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

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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours after surgery

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

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 more

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.

0 / 3Eligibility criteria met

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

Bupivacaine 0.5% with 1:200 000 epinephrine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04427904 — Phase 2

Postoperative Pain Research Study Groups: Bupivacaine, Lidocaine

Postoperative Pain 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Bupivacaine 0.5% with 1:200 000 epinephrine a safe option for individuals?

"The safety of bupivacaine 0.5% with 1:200 000 epinephrine has been estimated to be a 2, as this is only in the second phase of clinical trials and there are some data points showing its safety but none demonstrating efficacy."

Answered by AI

Is there still capacity in this clinical trial to enroll new participants?

"Correct. According to clinicaltrials.gov, this trial is actively seeking participants after being initially posted on June 1st 2022 and recently updated on October 29th 2022."

Answered by AI

Is this trial accessible to geriatric participants?

"This study looks for participants aged between 18 and 100, as stated in the inclusion criteria. There are 131 trials specifically catered to minors under 18, while 776 ones target seniors over 65."

Answered by AI

What is the upper-limit of enrollees for this clinical investigation?

"Indeed, the details on clinicaltrials.gov confirm that this experiment is still enrolling participants. It was initially posted on June 1st 2022 and revised as recently as October 29th 2022, with a total of 210 people sought from one research site."

Answered by AI

Is there any precedence for utilizing the combination of Bupivacaine 0.5% and 1:200 000 epinephrine in clinical investigations?

"Currently, there are a total of 228 clinical trials investigating the efficacy and safety of Bupivacaine 0.5% with 1:200 000 epinephrine - 53 in Phase 3 specifically. The majority of these medical studies are being conducted at Germantown, Tennessee; however, across the whole United States 1259 sites have been established for this purpose."

Answered by AI

Who meets the requirements to become an active participant in this clinical trial?

"This clinical trial is enrolling 210 individuals with thyroid disorders, aged 18 to 100. To qualify for this study, enrollees must agree to remain in hospital post operation and have a proposed midline neck incision (total thyroidectomy or completion thyroidectomy with/without central dissection)."

Answered by AI

In which conditions is the combination of Bupivacaine 0.5% with 1:200 000 epinephrine most often prescribed?

"Ophthalmia, sympathetic can be managed with the application of a Bupivacaine 0.5% solution combined with 1:200 000 epinephrine. This combination has also proven successful in treating laryngotracheobronchitis, unresponsive bradycardia and pemphigus."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

Michael Xie 2022. "Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04427904.

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