Bupivacaine With Epinephrine for Shoulder Pain

Overseen By Kelly Wright, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Opioids, Amide anesthetics

Disqualifiers: Pregnancy, Chronic pain, 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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether spraying bupivacaine with epinephrine over the diaphragm during surgery can reduce shoulder pain after laparoscopic gynecologic surgery. Laparoscopy involves small incisions, and patients sometimes experience shoulder pain afterward. The study will compare the effects of bupivacaine with epinephrine to a placebo (a saline solution without active medication) to determine its effectiveness. Candidates for participation include those scheduled for laparoscopic gynecologic surgery at Cedars-Sinai Medical Center who do not have existing shoulder pain. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit 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. However, if you use opioids or have chronic pain, you may not be eligible to participate.

What is the safety track record for bupivacaine with epinephrine?

Research has shown that using bupivacaine with epinephrine is generally safe for surgeries. Bupivacaine, a local anesthetic, numbs a specific area during or after surgery. When combined with epinephrine, it lasts longer and effectively reduces pain. Studies have found that applying bupivacaine at the surgical site can significantly lessen post-surgical pain, especially in shoulder operations.

For this specific use above the diaphragm, direct studies are not yet available. However, the treatment is in a Phase 4 trial, indicating it has been tested in many patients and is generally considered safe. This trial explores a new application of bupivacaine with epinephrine to assess its effectiveness in managing shoulder pain after laparoscopic surgery. While the application method is new, the drugs themselves are well-known and usually well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for shoulder pain that often involve oral painkillers or steroid injections, bupivacaine with epinephrine offers a targeted approach by being administered laparoscopically over the diaphragm. This method allows for a more concentrated delivery directly at the site of pain, potentially enhancing its effectiveness. Additionally, the combination of bupivacaine, a long-acting local anesthetic, with epinephrine, which helps prolong the anesthetic's effects, could lead to longer-lasting pain relief compared to traditional options. Researchers are excited about this treatment because it could reduce the need for systemic medications, which often come with more significant side effects.

What evidence suggests that bupivacaine with epinephrine might be an effective treatment for postoperative shoulder pain?

Research has shown that bupivacaine with epinephrine effectively relieves pain in many surgeries. It is often used for nerve blocks, particularly in shoulder surgeries, to reduce pain. Studies have found that bupivacaine significantly lessens post-surgical pain and decreases the need for opioids, which are strong pain medications. In this trial, one group of participants will receive bupivacaine with epinephrine applied over the diaphragm to manage shoulder pain after laparoscopic surgery. Its overall effectiveness in controlling pain is well established. This treatment is approved and widely trusted for reducing surgical pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients experiencing postoperative shoulder pain after laparoscopic surgery. Participants should be undergoing benign gynecologic surgery at Cedar Sinai Medical Center and are willing to try a new method of pain management.

Inclusion Criteria

Provide a signed and dated informed consent form

I am willing and able to follow all study requirements.

I am 8 years old or older.

Exclusion Criteria

I am scheduled for a surgery that is not related to female reproductive organs.

I have shoulder pain.

I am currently using opioids for pain management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo laparoscopic gynecologic surgery with bupivacaine with epinephrine applied over the diaphragm

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored in the post-anaesthesia care unit (PACU) for pain and recovery

up to 6 hours

Continuous monitoring

Follow-up

Participants report postoperative shoulder pain scores at home and are monitored for safety and effectiveness

1 week

Daily self-reports

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine with Epinephrine

Trial Overview

The study tests if spraying bupivacaine with epinephrine over the diaphragm can reduce shoulder pain after laparoscopy, compared to a placebo (saline). It's an investigation into a potential new application of local anesthetic for post-surgery comfort.

How Is the Trial Designed?

Group I: Bupivacaine with epinephrine Experimental Treatment 1 Intervention

Participants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure.

Group II: No intervention Active Control 1 Intervention

No additional intervention will be performed.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07400146

Bupivacaine With Epinephrine Over Diaphragm in ...

However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12661793/

Efficacy and safety of co-administered bupivacaine and ... - PMC

Brachial plexus nerve blockade is considered optimal analgesia for shoulder surgeries and provides effective pain control [2]. Although ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1058274624000806

Shoulder Liposomal bupivacaine provides superior pain ...

The primary outcome was 120-hour postoperative opioid consumption. Secondary outcomes were pain scores up to 96 hours postoperatively, pain control satisfaction ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/46/NCT07400146/Prot_SAP_000.pdf

A Randomized Control Trial NCT Numb

bupivacaine with epinephrine on post-operative pain scores for shoulder pain. Secondary Objectives: To evaluate the impact of instilling ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12287184/

Shoulder pain after laparoscopic antireflux surgery - PMC - NIH

Primary outcomes included overall pain and postoperative use of opioids. The secondary outcomes were pain frequency and severity by anatomical ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091217357380

Pain Double-blind comparison of intrapleural saline and ...

Intrapleural administration of 40 ml of bupivacaine 0.25% does not provide effective pain relief for ipsilateral post-thoracotomy shoulder pain.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04134442

Improving Pain Management After Total Shoulder ...

The results showed the likelihood that liposomal bupivacaine and nerve blocks no longer offer significant contribution. Decision was made to terminate the study ...