100 Participants Needed

Lidocaine vs Bupivacaine for Postoperative Pain

MC
KB
Overseen ByKatie Bridges
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Boston Children's Hospital
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 information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Bupivacaine for postoperative pain?

Research shows that Bupivacaine, also known as Marcaine or Sensorcaine, is effective in managing postoperative pain due to its long-lasting effects and favorable safety profile. It has been used successfully in surgeries like breast reduction and obstetrical procedures, providing good pain relief with minimal side effects.12345

Is bupivacaine generally safe for use in humans?

Bupivacaine, also known as Marcaine or Sensorcaine, is generally considered safe for use in humans when used at recommended doses, with limited side effects reported in various surgical and obstetrical settings.12367

How do lidocaine and bupivacaine differ in managing postoperative pain?

Bupivacaine provides a longer duration of pain relief and requires fewer additional pain medications compared to lidocaine, making it a preferred choice for managing postoperative pain.158910

What is the purpose of this trial?

In this research study, we want to learn more about the impact of two different local anesthetics (bupivacaine and lidocaine) on patient experience following orthognathic (jaw) surgery. Both anesthetics are within the standard of care for dental and orthognathic procedures, but can vary in how quickly they take action and how long they last. This study will provide us with a greater understanding of how anesthetic choice affect patient outcomes, and how we can strive to make these outcomes as favorable as possible.

Research Team

MA

Mark A Green, DDS, MD

Principal Investigator

Boston Children's Hospital, Department of Plastic and Oral Surgery

Eligibility Criteria

This trial is for individuals aged 15-35 undergoing jaw surgery at Boston Children's Hospital. It aims to compare the effects of two local anesthetics on patient recovery.

Inclusion Criteria

I am scheduled for jaw surgery at Boston Children's Hospital.
I am between 15 and 35 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks
1 visit (in-person)

Treatment

Participants undergo orthognathic surgery with administration of bupivacaine and lidocaine as local anesthetics

1 day
1 visit (in-person)

Immediate Postoperative Assessment

Participants are assessed for numbness, light touch perception, temperature sensation, and pain approximately one hour and four hours after surgery

1 day
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of numbness, light touch perception, temperature sensation, and pain one week after surgery

1 week
1 visit (in-person)

Treatment Details

Interventions

  • Bupivacaine
  • Lidocaine
Trial Overview The study tests lidocaine and bupivacaine, both used in dental procedures, to see which provides better outcomes post-surgery. Patients will receive one of these drugs during their operation.
Participant Groups
2Treatment groups
Active Control
Group I: Bupivacaine Left, Lidocaine RightActive Control2 Interventions
Group 1 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the left side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.
Group II: Bupivacaine Right, Lidocaine LeftActive Control2 Interventions
Group 2 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the right side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the left side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
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Approved in European Union as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
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Approved in Canada as Sensorcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Findings from Research

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]
In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.
Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.
Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty.Culliford, AT., Spector, JA., Flores, RL., et al.[2021]
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

Bupivacaine: a review. [2018]
Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]
[The use of Marcaine in obstetrical analgesia]. [2013]
4.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]
[Postoperative analgesia using epidural administration of bupivacaine plus lidocaine]. [2013]
Spinal anesthesia: bupivacaine compared with tetracaine. [2013]
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. [2023]
Comparison of postoperative bupivacaine with lidocaine on pain and analgesic use following periodontal surgery. [2013]
A comparison of postoperative pain experience following periodontal surgery using two local anesthetic agents. [2013]
Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. [2014]
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