Local Anesthetics for Postoperative Pain in Thyroid Surgery
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.12345Why 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.23567Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive local infiltration with either Bupivacaine or Lidocaine before neck incision during thyroid surgery
Postoperative Monitoring
Participants are monitored for postoperative pain and analgesia utilization
Follow-up
Participants are monitored for complications and return of sensation at the surgical site
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine 0.5% with 1:200 000 epinephrine
- Lidocaine 2% with 1:100 000 epinephrine
Bupivacaine 0.5% with 1:200 000 epinephrine is already approved in United States, Canada, European Union for the following indications:
- Local anesthesia
- Postoperative pain
- Cesarean section
- Local anesthesia
- Postoperative pain
- Local anesthesia
- Regional anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Joseph's Healthcare Hamilton
Lead Sponsor