Local Anesthetics for Postoperative Pain in Thyroid Surgery

Overseen By Han Zhang, MD FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Narcotics, Chronic pain meds

Disqualifiers: Diabetes, Renal disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two local anesthetics, Bupivacaine and Lidocaine, to determine which better controls pain after thyroid surgery. Researchers compare the effectiveness of each drug when administered before surgery. Individuals planning thyroid surgery with a neck incision, for conditions like thyroid tumors, might be suitable candidates.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Bupivacaine and Lidocaine are generally safe for managing post-surgical pain. Studies have found that Bupivacaine, particularly in its liposomal form, is well-tolerated and effectively relieves pain, with most people not experiencing serious side effects.

For Lidocaine, research indicates it effectively reduces post-surgical pain. However, using the correct dose is crucial, as excessive amounts can lead to serious side effects. When administered properly, Lidocaine is safe and effective for pain management.

Both treatments have been widely used and have a good safety record, rarely causing harmful side effects when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because Bupivacaine and Lidocaine, both used with epinephrine, offer unique benefits for managing postoperative pain in thyroid surgery. Unlike standard pain relief options that may rely on systemic opioids, these treatments are locally administered, which can lead to fewer side effects like nausea or drowsiness. Bupivacaine, known for its long-lasting effects, can provide extended pain relief, while Lidocaine acts quickly to numb pain. By using these local anesthetics, the goal is to enhance recovery and improve patient comfort right after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain in thyroid surgery?

This trial will compare the effectiveness of two local anesthetics for managing postoperative pain in thyroid surgery. Research has shown that bupivacaine with epinephrine, which participants in this trial may receive, can significantly reduce pain after thyroid surgery. Patients using this combination often require less additional pain medication. Bupivacaine blocks pain signals in the nerves around the surgery area, and studies have demonstrated that it lowers pain levels, making recovery more comfortable.

Lidocaine, also mixed with epinephrine, is another treatment option in this trial for managing postoperative pain. It works quickly to numb the area and is widely used in various medical procedures. While both treatments aim to ease pain, bupivacaine often provides longer-lasting effects compared to lidocaine. ^{2 3 5 6 7}

Who Is on the Research Team?

Han Zhang, MD FRCSC

Principal Investigator

St. Joseph's Hospital Hamilton

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Bupivacaine Experimental Treatment 1 Intervention

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Group II: Lidocaine Active Control 1 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

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Published Research Related to This Trial

In a study of 435 patients, bupivacaine (0.75% in 8.25% dextrose) demonstrated superior efficacy compared to tetracaine for spinal anesthesia, with only one unsatisfactory anesthesia case in the bupivacaine group versus 19 in the tetracaine group for the lower dose.

Bupivacaine was found to be a safe and reliable option for spinal anesthesia, although tetracaine provided longer motor blockade; adding epinephrine to either anesthetic significantly extended their duration of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. Moore, DC.[2013]

In a study of 90 patients undergoing thyroid surgery, bilateral superficial cervical plexus blocks using bupivacaine significantly reduced the proportion of patients requiring morphine for pain management (66% vs 90% for placebo).

Patients receiving bupivacaine also reported lower initial pain scores compared to those receiving a placebo, indicating that this local anesthetic infiltration effectively alleviates postoperative pain, although it may not completely eliminate the need for additional pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. Dieudonne, N., Gomola, A., Bonnichon, P., et al.[2022]

In a study of 40 patients undergoing thyroidectomy, those who received intravenous lidocaine during surgery reported significantly lower postoperative pain scores at multiple time points compared to a control group, indicating its efficacy in pain management.

The lidocaine group also required less additional analgesia post-surgery, suggesting that lidocaine not only reduces pain but may also decrease the need for other pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of Intraoperative lidocaine infusion in patients undergoing thyroidectomy. Akgul, E., Gozeler, MS., Kars, A., et al.[2023]

In a study of 40 patients undergoing thyroid surgery, the use of bupivacaine 0.5% for wound infiltration significantly reduced postoperative pain scores compared to those who did not receive the infiltration, with scores of 3.7 versus 6.9 on a scale of 0 to 10.

Patients who received bupivacaine required significantly less opioid medication post-surgery, with only 30% needing opioids compared to 90% in the control group, demonstrating that bupivacaine infiltration is an effective and safe method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine wound infiltration in thyroid surgery reduces postoperative pain and opioid demand. Gozal, Y., Shapira, SC., Gozal, D., et al.[2022]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 111 patients undergoing total thyroidectomy, bilateral superficial cervical plexus block with 0.75% ropivacaine, whether administered before or after surgery, did not improve postoperative pain management compared to no block.

There were no significant differences in morphine requirements, pain intensity scores, or overall opioid consumption among the groups, indicating that this method of analgesia may not be effective for enhancing pain relief in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Herbland, A., Cantini, O., Reynier, P., et al.[2022]

In a study of 101 patients undergoing thyroid surgery, multimodal analgesia using 1% lidocaine wound infiltration combined with intravenous parecoxib significantly reduced postoperative pain intensity during movement and coughing, especially in patients receiving a higher dose of lidocaine (10 mL) compared to a lower dose (5 mL).

The analgesic approach was safe, with no severe adverse events reported, and only one patient experienced temporary vocal palsy, indicating that this method of pain management is effective and has a low risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia with Local Wound Infiltration and Intravenous Parecoxib for Thyroidectomy. Gau, TP., Wu, SH., Huang, JM., et al.[2023]

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