Bupivacaine for Postoperative Pain After Hysterectomy

Overseen By Hosam Hanna, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: MediSys Health Network

Must not be taking: Tramadol, Oxycodone

Disqualifiers: Multiple surgeries, Cardiac history, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 hours

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you use significant pre-op pain medication, you may not be eligible to participate.

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

Research shows that Bupivacaine, also known as Marcaine or Sensorcaine, is effective in managing postoperative pain in various surgeries, such as breast reduction, by reducing discomfort and the need for additional pain medication. However, a study specifically on abdominal hysterectomy found that local anesthetic infiltration with Bupivacaine did not significantly reduce pain, suggesting its effectiveness may vary depending on the type of surgery. ^{1 2 3 4 5}

Is Bupivacaine safe for use in humans?

Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe when used correctly, with limited side effects reported in various medical procedures. In a review of 11,080 cases, only 15 systemic toxic reactions occurred, and no serious long-term effects were noted. It is important to follow dosage recommendations to minimize risks. ^{1 3 5 6 7}

How does the drug bupivacaine differ from other treatments for postoperative pain after hysterectomy?

Bupivacaine is unique because it can be administered directly into the peritoneal cavity (the space within the abdomen) after a laparoscopic hysterectomy to reduce postoperative pain, which is different from other treatments that may not target this specific area. Additionally, it is known for providing effective pain relief with minimal side effects when used in appropriate doses. ^{1 2 4 7 8}

What is the purpose of this trial?

The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.

Eligibility Criteria

This trial is for individuals who have undergone a hysterectomy and are experiencing postoperative pain. Participants should not currently have infections or other conditions that could interfere with the study.

Inclusion Criteria

I am 18 or older and need a laparoscopic hysterectomy for a non-cancerous condition.

I have cancer.

Exclusion Criteria

My surgery was changed to an open procedure.

Poor initial Aldrete score (<10)

I am not allergic to Bupivacaine, epinephrine, tramadol, or oxycodone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure

4 hours

Follow-up

Participants are monitored for changes in pain score and overall satisfaction after treatment

1 week

Treatment Details

Interventions

• Bupivacaine

Trial Overview The study aims to see if injecting Bupivacaine, a local anesthetic, into the vaginal cuff before closing it up after surgery can reduce the need for pain meds afterwards and improve comfort.

Participant Groups

Group I: Vaginal Cuff Anesthesia Experimental Treatment 1 Intervention

Group II: Vaginal Cuff Saline Placebo Group 1 Intervention

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?

MediSys Health Network

Lead Sponsor

Trials

5

Recruited

250+

Findings from Research

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 160 women undergoing laparoscopic hysterectomy, the use of intraperitoneal bupivacaine did not significantly reduce postoperative pain compared to a placebo, as measured by visual analog scale scores at multiple time points.

There were no significant differences in opioid use, length of hospital stay, patient satisfaction, or complication rates between the bupivacaine and placebo groups, indicating that bupivacaine may not provide additional benefits in pain management for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal instillation of bupivacaine for reduction of postoperative pain after laparoscopic hysterectomy: a double-blind randomized controlled trial. Arden, D., Seifert, E., Donnellan, N., et al.[2013]

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 double-blind trial with 40 patients undergoing abdominal hysterectomy, preoperative infiltration of 0.25% bupivacaine did not significantly reduce postoperative pain or morphine consumption compared to normal saline.

The study found that visceral pain was the main type of pain experienced in the first 48 hours after surgery, suggesting that effective pain management should focus on addressing this type of pain rather than relying on local anesthetic infiltration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pre-incision skin infiltration on post-hysterectomy pain--a double-blind randomized controlled trial. Leung, CC., Chan, YM., Ngai, SW., et al.[2019]

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, 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]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

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

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

Intraperitoneal instillation of bupivacaine for reduction of postoperative pain after laparoscopic hysterectomy: a double-blind randomized controlled trial. [2013]

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

Bupivacaine: a review. [2018]

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

Effect of pre-incision skin infiltration on post-hysterectomy pain--a double-blind randomized controlled trial. [2019]

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

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

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

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

7. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

8. 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]