Bupivacaine-Epinephrine for Postoperative Pain

Overseen By Marcella Willis-Gray, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English speaking, Allergy to bupivacaine, others

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

Compensation: Varies

Number of Visits: 4

Duration: Day of surgery

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a numbing injection around the cervix can reduce pain and the need for strong painkillers after surgery for vaginal hysterectomy with prolapse repair. Researchers aim to determine if this approach can decrease opioid use post-surgery. Participants will receive either the numbing medicine (bupivacaine with lidocaine and epinephrine) or a placebo (saltwater solution). Ideal candidates for the trial are those undergoing this specific surgery who do not have allergies to the medicine. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

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 is the safety track record for the paracervical injection with bupivacaine and epinephrine?

Studies have shown that paracervical blocks with bupivacaine and epinephrine are generally safe and effective. These pain relief methods have been used since the 1970s to manage post-surgical pain. Research indicates they can effectively reduce pain without major issues. Available studies report no serious side effects linked to these blocks, suggesting most people tolerate the treatment well. However, individual experiences can vary with any medical treatment. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using a paracervical block with bupivacaine and epinephrine for postoperative pain management because it offers a targeted approach, potentially leading to more effective pain relief during vaginal hysterectomy with prolapse repair. Unlike standard oral or intravenous pain medications, this localized injection delivers the anesthetic directly to the affected area, which might result in faster and more effective pain control. Additionally, the combination of bupivacaine, a long-acting anesthetic, with epinephrine, a vasoconstrictor that prolongs the anesthetic effect, could reduce the need for systemic pain medications, minimizing side effects and improving recovery times.

What evidence suggests that this paracervical block is effective for reducing postoperative opioid use?

Research has shown that a paracervical block with bupivacaine and epinephrine effectively reduces pain after surgery. In this trial, one group of participants will receive a paracervical block with 0.5% bupivacaine and epinephrine during a vaginal hysterectomy with prolapse repair. A review of several studies found that this method lowered pain levels at both 30 and 60 minutes after a minimally invasive hysterectomy. Another study confirmed that using a local anesthetic like bupivacaine before surgery led to better pain relief. These findings suggest that bupivacaine with epinephrine might reduce the need for opioid painkillers after a vaginal hysterectomy with prolapse repair. Overall, the evidence supports the effectiveness of paracervical blocks in managing post-surgical pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Bertie Geng, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

This trial is for individuals undergoing vaginal hysterectomy with prolapse repair. Participants should be willing to record pain medication use and report pain scores after surgery. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am having a vaginal hysterectomy and prolapse repair at the same time.

Exclusion Criteria

I weigh less than 50 kg.

Non-English speaking

Allergy to bupivacaine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a paracervical block with bupivacaine and lidocaine or a placebo injection during vaginal hysterectomy with prolapse repair

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Participants report pain scores and opioid use on the day of surgery, and on days 1 and 7 post-surgery

1 week

2 visits (virtual)

Follow-up

Participants complete a surgical recovery questionnaire and are assessed for adverse events during a 6-week postoperative visit

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Paracervical Injection

Trial Overview The study tests if a paracervical block using bupivacaine with lidocaine reduces the need for opioids post-surgery compared to a placebo (saltwater liquid). Patients will receive either the numbing medicine or placebo before other surgical procedures begin.

How Is the Trial Designed?

Group I: Paracervical block Experimental Treatment 1 Intervention

Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468784721000945

Role of paracervical block in reducing postoperative pain ... In this meta-analysis, we found that paracervical anesthetic block was effective in reducing induced pain both at 30 and 60 min after laparoscopic hysterectomy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6174006/

Use of Paracervical Block Before Laparoscopic Supracervical ... Conclusion: Paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy did not decrease overnight admission rate or ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03027661

Para-cervical Block Prior to Laparoscopic Hysterectomy as ... -Determine if infiltrating the cervical stroma with local anesthetic prior to performing a hysterectomy will reduce postoperative pain scores, and hence ...

4. imrpress.com imrpress.com/journal/CEOG/49/3/10.31083/j.ceog4903066/htm

Paracervical block in laparoscopic hysterectomy for ... The aim of this study was to evaluate the efficacy of a paracervical block on postoperative pain relief when applied with preemptive local analgesia using 0.5% ...

5. dune.une.edu dune.une.edu/cgi/viewcontent.cgi?article=1037&context=na_capstones

Exparel Versus Bupivacaine: Outcomes, Advantages, And Costs Several outcomes will be considered including postoperative pain, opioid requirements, length of hospital stay (LOS), patient outcomes, and cost. Bupivacaine.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01534416

Effect of Paracervical Block on Post Operative Pain ... Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they ...