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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a local anesthetic called Bupivacaine can reduce pain and improve comfort after a hysterectomy. Researchers aim to determine if an injection at the end of surgery reduces the need for pain medication afterward. The trial includes two groups: one receiving the anesthetic and the other a saline placebo (inactive substance). Women undergoing a laparoscopic hysterectomy for non-cancerous reasons may qualify, provided they do not have complex medical issues or already use significant pain medication. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Bupivacaine?

Research has shown that Bupivacaine is generally safe and effective for pain relief after surgery. One study found that injecting Bupivacaine at the surgery site effectively reduced pain after a laparoscopic hysterectomy and was safe for patients. Another study demonstrated that Bupivacaine helped manage pain immediately after surgery. These findings suggest that Bupivacaine is a reliable option for controlling pain during surgery, with a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about bupivacaine for postoperative pain management after a hysterectomy because it offers a localized pain relief method directly applied to the vaginal cuff. Unlike systemic pain medications that can affect the whole body, bupivacaine acts specifically at the surgical site, potentially reducing the need for opioids and their associated side effects. This targeted approach could lead to more effective pain control with fewer complications, making recovery smoother and more comfortable for patients.

What is the effectiveness track record for Bupivacaine in reducing postoperative pain after hysterectomy?

Research has shown that Bupivacaine reduces pain after surgery. In this trial, participants will receive either Bupivacaine or a saline placebo at the vaginal cuff following a hysterectomy. Studies have found that injecting Bupivacaine at the surgery site, such as after a hysterectomy, significantly lowers pain levels 6 and 24 hours post-operation. Another study found that using Bupivacaine at small incision sites during laparoscopic hysterectomy effectively reduced pain. Additionally, Bupivacaine helps manage pain when used to numb the area around the cervix. Overall, these findings support Bupivacaine's ability to decrease pain and improve comfort after surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8421670/

A Systematic Review and Meta-Analysis of Intraperitoneal ...

Bupivacaine significantly reduced the visual analog pain score for pain compared with that of the placebo at 6 and 24 hours postoperatively.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0301211520304474

Impact of bupivacaine injection to trocar sites on ...

The present study suggests that bupivacaine injection to trocar sites is an effective and safe method for reducing pain following laparoscopic hysterectomy.

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/30/NCT06120530/Prot_SAP_000.pdf

Effect of intraperitoneal Bupivacaine on postoperative pain ...

It has been documented that infiltration of local anesthetics has been shown to effectively control postoperative pain for patients undergoing laparoscopic, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8936873/

Comparative Study of Postoperative Pain Relief Using ...

Subcutaneous infiltration of Bupivacaine either pre-incisional or post-incisional, helped to reduce the immediate post-operative pain intensity, delayed the ...

5.

liebertpub.com

liebertpub.com/doi/10.1177/10424067251392386

Paracervical Block for Immediate Postoperative Pain ...

The results of this study demonstrate that paracervical block with bupivacaine is an effective strategy for managing postoperative pain in TLH.

6.

fda.gov

fda.gov/media/134721/download

SABER®-Bupivacaine

• Helps cover the period of greatest postoperative pain. • Can ... • Safety data from the PERSIST study. • Safety data from the PERSIST ...

7.

ajog.org

ajog.org/article/s0002-9378(17)30424-6/fulltext

Preemptive analgesia for postoperative hysterectomy pain ...

The objective of the study was to investigate the effectiveness of preemptive analgesia at pain control in women undergoing total abdominal hysterectomy.