Lidocaine vs Bupivacaine for Postoperative Pain

Overseen By Katie Bridges

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Children's Hospital

Disqualifiers: Chronic pain, Allergic reactions, Pregnancy, 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: 5

Duration: 1 day

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 5 8 9 10}

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

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

Group I: Bupivacaine Left, Lidocaine Right Active Control 2 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 Left Active Control 2 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:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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 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]

In a randomized clinical trial involving 30 patients undergoing lower abdominal surgery, the combination of bupivacaine and lidocaine provided longer postoperative analgesia compared to lidocaine alone.

Both groups experienced similar latency periods and no serious complications, indicating that the bupivacaine + lidocaine mixture is a safe and effective option for epidural anesthesia in this surgical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia using epidural administration of bupivacaine plus lidocaine]. Rodríguez-Nava, A., Castañeda-Baena, R., Ramírez-Ramírez, M., 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]

The bupivacaine implant (XARACOLL) significantly reduced pain intensity in the first 24 hours after abdominoplasty compared to placebo, indicating its efficacy in providing postoperative analgesia.

Patients receiving the bupivacaine implant had a higher percentage of opioid-free patients at 24, 48, and 72 hours post-surgery, suggesting it may help reduce reliance on opioids for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Beaton, AC., Solanki, D., Salazar, H., et al.[2023]

Bupivacaine, a long-acting local anesthetic, provided significantly longer postoperative anesthesia (5.62 hours) compared to lidocaine (2.47 hours) after periodontal surgery in a study involving 10 male subjects.

Patients who received bupivacaine reported significantly less pain and required fewer analgesics (1.60 tablets) compared to those who received lidocaine (3.70 tablets), indicating its superior efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of postoperative bupivacaine with lidocaine on pain and analgesic use following periodontal surgery. Kaurich, MJ., Otomo-Corgel, J., Nagy, RJ.[2013]

In a study involving 20 patients undergoing standardized periodontal surgery, bupivacaine HCl resulted in significantly less postoperative pain and a longer duration of numbness compared to lidocaine HCl.

Patients reported a strong preference for bupivacaine, which also led to fewer analgesics being taken post-surgery, indicating its potential for improved pain management in periodontal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of postoperative pain experience following periodontal surgery using two local anesthetic agents. Linden, ET., Abrams, H., Matheny, J., et al.[2013]

In a study of 130 patients, 50 mg of plain 1% 2-chloroprocaine was found to have a similar onset time for sensory block at the T10 level compared to 10 mg of plain 0.5% bupivacaine, supporting its use as an effective spinal anesthetic.

2-chloroprocaine demonstrated faster recovery times for motor block, sensory block resolution, and overall ambulation compared to bupivacaine, with no reported cases of transient neurological symptoms, indicating a potentially safer profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Camponovo, C., Wulf, H., Ghisi, D., et al.[2014]

References

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

Bupivacaine: a review. [2018]

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

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

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

[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]

5. Mexico pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia using epidural administration of bupivacaine plus lidocaine]. [2013]

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

Spinal anesthesia: bupivacaine compared with tetracaine. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. [2023]

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

Comparison of postoperative bupivacaine with lidocaine on pain and analgesic use following periodontal surgery. [2013]

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

A comparison of postoperative pain experience following periodontal surgery using two local anesthetic agents. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. [2014]