TAP Blocks with Ropivacaine vs Liposomal Bupivacaine for Postoperative Pain

Overseen By Ana Arias, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Davis

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Pregnancy, Prisoners, Hypersensitivity, 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: Unknown

Duration: 4 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which pain relief method works better after surgery for kidney transplant patients. Researchers are comparing two types of nerve blocks: one uses a continuous flow of ropivacaine, a pain-relieving medicine, and the other uses a single dose of liposomal bupivacaine, which releases slowly over time. Participants should be kidney transplant recipients not regularly taking high doses of pain medication. The goal is to identify which method more effectively reduces pain after surgery. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, seeking to understand how they 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, but if you are taking more than 30 mg/day of opioid painkillers or are on blood thinners, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that both ropivacaine and liposomal bupivacaine are generally safe and effective for relieving post-surgical pain. Studies have found that a continuous infusion of ropivacaine safely speeds recovery by effectively managing pain, with no major safety concerns reported.

For liposomal bupivacaine, research indicates it is also safe for pain control. Common side effects include nausea, fever, and constipation, occurring in about 10% of cases. No serious safety issues have been reported when used for nerve blocks.

Both treatments have been widely used and have a strong safety record, making them good options for managing post-surgical pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain because they offer innovative approaches to pain management. The Ropivacaine Continuous Infusion Catheter is unique because it delivers a continuous infusion of ropivacaine directly to the site through a TAP block, potentially providing consistent pain relief over time. On the other hand, Single Dose Liposomal Bupivacaine stands out by using liposomal technology to prolong the drug's effect from a single administration, potentially reducing the need for additional doses. Both methods aim to enhance patient comfort and recovery by offering more sustained and targeted pain control compared to traditional options like oral opioids or standard local anesthetics.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare the effectiveness of two treatments for postoperative pain management: a continuous infusion of ropivacaine and a single dose of liposomal bupivacaine. Research has shown that a continuous drip of ropivacaine, which participants in one arm of this trial may receive, controls pain effectively after surgery. It provides better pain relief and speeds recovery compared to some other methods, also reducing the need for additional pain medication. Conversely, studies have found that liposomal bupivacaine, which participants in another arm of this trial may receive, does not relieve pain as effectively as ropivacaine. In many cases, it neither aids recovery nor reduces pain effectively. Overall, ropivacaine appears more dependable for managing pain after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who have received a kidney transplant and are experiencing postoperative pain. It's not suitable for those under 18, pregnant women, prisoners, patients with high opioid tolerance (taking more than 30 mg/day of oral morphine equivalent), on systemic anticoagulants, unable to consent, or allergic to amide-type local anesthetics.

Inclusion Criteria

I have received a kidney transplant.

Exclusion Criteria

I take more than 30 mg/day of pain medication similar to morphine.

You are allergic to a specific type of local anesthetic or any of the ingredients in the drug formula.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAP blocks with either ropivacaine continuous infusion or single dose liposomal bupivacaine for pain control after renal transplant surgery

4 days

Inpatient stay

Follow-up

Participants are monitored for pain scores, post-operative nausea, vomiting, respiratory depression, and length of stay

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine Continuous Infusion Catheter
• Single Dose Liposomal Bupivicaine

Trial Overview The study compares two types of pain relief after kidney transplant surgery: one group receives a TAP block with ropivacaine plus ongoing infusion via catheter; the other gets a single shot TAP block with liposomal bupivacaine.

How Is the Trial Designed?

Group I: Ropivacaine Continuous Infusion Catheter Active Control 1 Intervention

Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter.

Group II: Single dose liposomal bupivicaine Active Control 1 Intervention

Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline.

Ropivacaine Continuous Infusion Catheter is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Naropin for:

• Surgical anesthesia
• Acute pain management
• Epidural block for surgery
• Major nerve blocks
• Local infiltration

Approved in United States as Naropin for:

• Surgical anesthesia
• Acute pain management
• Epidural block for surgery
• Major nerve blocks
• Local infiltration

Approved in Canada as Naropin for:

• Surgical anesthesia
• Acute pain management
• Epidural block for surgery
• Major nerve blocks
• Local infiltration

Approved in Japan as Naropin for:

• Surgical anesthesia
• Acute pain management
• Epidural block for surgery
• Major nerve blocks
• Local infiltration

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a study involving patients undergoing robot-assisted hysterectomy, the use of liposomal bupivacaine in subcostal TAP blocks significantly reduced total opioid use in the first 72 hours post-surgery compared to standard bupivacaine.

Patients receiving liposomal bupivacaine reported lower maximum pain scores and had a decreased incidence of nausea and vomiting, suggesting improved overall satisfaction and comfort after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Hutchins, J., Delaney, D., Vogel, RI., et al.[2022]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

Liposomal bupivacaine offers a longer duration of action compared to traditional bupivacaine HCl, which can enhance postoperative pain control and potentially improve patient satisfaction.

Preliminary clinical trials indicate that liposomal bupivacaine has predictable pharmacokinetics and a similar side effect profile to bupivacaine HCl, suggesting it may reduce the need for opioids and associated adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine and clinical outcomes. Tong, YC., Kaye, AD., Urman, RD.[2022]

In a study of 50 patients undergoing vaginal reconstructive surgery, liposomal bupivacaine (LB) did not show any significant advantage over plain bupivacaine in terms of postoperative pain control, narcotic use, or length of hospital stay.

Despite LB's higher cost, the results indicate that it is not more effective than plain bupivacaine for managing pain after surgery, suggesting a need for further research to find the best pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. Jensen, S., Amasyali, AS., Keheila, M., et al.[2023]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

In a study of 219 patients undergoing weight loss surgeries, the use of liposomal bupivacaine (LB) for transversus abdominis plane (TAP) blocks did not significantly reduce postoperative narcotic use compared to regular bupivacaine (RB) or no TAP block.

Pain scores and other recovery metrics, such as length of stay and time to ambulation, were similar across all groups, indicating that LB did not provide a clear advantage in pain management for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial. Wong, KA., Cabrera, AG., Argiroff, AL., et al.[2021]

A case report highlights a significant safety concern regarding the use of liposomal bupivacaine in transversus abdominis plane (TAP) blocks, as an elderly patient experienced postoperative respiratory depression after surgery.

This incident raises questions about the pharmacokinetics and safety of liposomal bupivacaine, especially when used alongside intravenous opioids and other analgesics in multimodal pain management after open abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Respiratory Depression Secondary to Opioid Overdose After Multimodal Analgesia With Transversus Abdominis Plane Blocks in Postanesthesia Care Unit: A Case Report. O'Rourke, M., Schmidt, ES., Metry, JE., et al.[2021]

In a study of 100 patients undergoing elective laparoscopic colectomy, those receiving liposomal bupivacaine TAP blocks required significantly less narcotic medication (5.06 mg) compared to those receiving standard bupivacaine (18.75 mg), indicating better pain management.

Patients treated with liposomal bupivacaine also experienced earlier bowel function (1.7 days vs 2.4 days) and shorter hospital stays (2.7 days vs 3.4 days), suggesting improved postoperative recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Surgery: Better Pain Control and Patient Outcomes with Liposomal Bupivacaine than Bupivacaine. Guerra, L., Philip, S., Lax, EA., et al.[2020]

Liposomal bupivacaine significantly extends the duration of pain relief compared to traditional bupivacaine HCL, making it a more effective option for post-operative pain management.

Clinical studies indicate that liposomal bupivacaine not only improves patient satisfaction but also reduces hospital admissions and the risk of opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine For Pain Control. Beiranvand, S., Moradkhani, MR.[2018]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

In a study of 287 patients undergoing colorectal surgery, the timing of transversus abdominis plane (TAP) blocks with liposomal bupivacaine (before or after anesthesia induction) did not significantly affect postoperative pain scores or opioid consumption.

However, patients who received TAP blocks after surgery required more ketorolac, indicating that while timing may not impact pain control, it could influence the use of additional non-opioid analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Transversus Abdominis Plane Block and Postoperative Pain Management. Escudero-Fung, M., Lehman, EB., Karamchandani, K.[2022]

A review of 76 randomized controlled trials found that only 11% showed a significant benefit of liposomal bupivacaine over standard bupivacaine or ropivacaine for postoperative pain control.

The majority of trials indicated that unencapsulated bupivacaine provided better pain relief than liposomal bupivacaine, suggesting that routine use of liposomal bupivacaine may not be justified based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Ilfeld, BM., Eisenach, JC., Gabriel, RA.[2021]

Citations

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Pain Effectiveness of continuous wound infusion of 0.5% ... Continuous surgical wound infusion with ropivacaine improved pain relief and accelerated recovery and discharge reducing overall costs of care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4483959/

Postoperative continuous wound infusion of ropivacaine ... Continuous wound infusion with ropivacaine is effective for postoperative analgesia and has comparable effects to traditional PCA with sufentanil.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7480288/

Continuous preperitoneal infusion of ropivacaine for ... Continuous preperitoneal infusion provides a superior analgesic effect than the continuous epidural infusion as regards delayed first request of analgesia.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03349034

Local Infusion of Ropivacaine for Post-Op Pain Control ... In this study the clinical team aims to better control donor site pain utilizing local, targeted analgesia to relieve pain at the donor site for osseocutaneous ...

5. karger.com karger.com/esr/article/53/1-4/43/128497/Ropivacaine-for-Continuous-Wound-Infusion-for

Ropivacaine for Continuous Wound Infusion ... Conclusion: This systematic review and meta-analysis presents substantial evidence that ropivacaine provides clinically meaningful reductions in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03737604

TAP Blocks With Ropivacaine Continuous Infusion ... This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362121/

Continuous Transversus Abdominis Plane Nerve Blocks Bilateral TAP catheters (posterior approach) were inserted in 24 healthy volunteers followed by ropivacaine 2 mg/mL administration for a total of 6 hours. The ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03149783

Study to Determine if Pre- and Post- Operative TAP ... The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain ...