210 Participants Needed

Local Anesthetics for Postoperative Pain in Thyroid Surgery

MX
HZ
Overseen ByHan Zhang, MD FRCSC
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Joseph's Healthcare Hamilton
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you have a history of using chronic pain medications in the past 6 months, you may not be eligible to participate.

What data supports the effectiveness of the drug Bupivacaine for postoperative pain management in thyroid surgery?

Research shows that bupivacaine, when used with epinephrine, improves pain relief after thyroid surgery. Additionally, bupivacaine is known for its long-lasting pain relief and favorable safety profile compared to other local anesthetics.12345

Is the use of local anesthetics like Bupivacaine generally safe for humans?

Bupivacaine, used in various forms and concentrations, has been shown to be generally safe in humans when used correctly, with minimal side effects. In a review of 11,080 cases, only 15 systemic toxic reactions were reported, and no serious long-term effects were noted.12367

How does the drug Bupivacaine with epinephrine differ from other treatments for postoperative pain in thyroid surgery?

Bupivacaine with epinephrine is unique because it is used as a local anesthetic directly infiltrated into the wound, which can significantly reduce postoperative pain and the need for opioids compared to not using any local anesthetic. This method targets pain at the surgical site, providing effective pain relief with minimal systemic side effects.4891011

What is the purpose of this trial?

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

Research Team

HZ

Han Zhang, MD FRCSC

Principal Investigator

St. Joseph's Hospital Hamilton

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for thyroid surgery involving a cut in the middle of my neck.
I will stay in the hospital for at least 12 hours after surgery.
I have been diagnosed with thyroid disease, either a small to medium tumor or benign condition.

Exclusion 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.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive local infiltration with either Bupivacaine or Lidocaine before neck incision during thyroid surgery

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative pain and analgesia utilization

72 hours

Follow-up

Participants are monitored for complications and return of sensation at the surgical site

4 weeks

Treatment Details

Interventions

  • Bupivacaine 0.5% with 1:200 000 epinephrine
  • Lidocaine 2% with 1:100 000 epinephrine
Trial Overview 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.
Participant Groups
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.

Bupivacaine 0.5% with 1:200 000 epinephrine is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Bupivacaine for:
  • Local anesthesia
  • Postoperative pain
  • Cesarean section
🇨🇦
Approved in Canada as Marcaine for:
  • Local anesthesia
  • Postoperative pain
🇪🇺
Approved in European Union as Bupivacaine for:
  • Local anesthesia
  • Regional anesthesia

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

Findings from Research

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).
The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.
Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study.Jacobus, D., Mehr, S., Ziccardi, V.[2021]
Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.
It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.
Bupivacaine: a review.Babst, CR., Gilling, BN.[2018]
Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.
When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.
[The use of Marcaine in obstetrical analgesia].Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

References

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. [2021]
Bupivacaine: a review. [2018]
[The use of Marcaine in obstetrical analgesia]. [2013]
The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. [2022]
Spinal anesthesia: bupivacaine compared with tetracaine. [2013]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]
Bupivacaine: a review of 11,080 cases. [2019]
Bupivacaine wound infiltration in thyroid surgery reduces postoperative pain and opioid demand. [2022]
Multimodal Analgesia with Local Wound Infiltration and Intravenous Parecoxib for Thyroidectomy. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. [2022]
Analgesic efficacy of Intraoperative lidocaine infusion in patients undergoing thyroidectomy. [2023]
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