Local Anesthetics for Postoperative Pain in Thyroid Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Han Zhang, MD FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Narcotics, Chronic pain meds

Disqualifiers: Diabetes, Renal disease, Liver disease, others

No Placebo Group

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{4 8 9 10 11}

Research Team

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.

Trial 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 (Local Anesthetic)
• Lidocaine 2% with 1:100 000 epinephrine (Local Anesthetic)

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

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 Canada for the following indications:

Approved in Canada as Marcaine for:

• Local anesthesia
• Postoperative pain

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Dr. Michael Heenan

St. Joseph's Healthcare Hamilton

Chief Executive Officer since 2023

PhD in Business Administration Health Policy Management, MBA in Health Services Management, and Bachelor of Arts from McMaster University

Dr. Sarah Jarmain

St. Joseph's Healthcare Hamilton

Chief Medical Officer

MD

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.

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 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 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 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 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]

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]

References

1. Germany 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]

3. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Bupivacaine wound infiltration in thyroid surgery reduces postoperative pain and opioid demand. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia with Local Wound Infiltration and Intravenous Parecoxib for Thyroidectomy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of Intraoperative lidocaine infusion in patients undergoing thyroidectomy. [2023]