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

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 are taking more than 30 mg/day of opioid painkillers or are on blood thinners, you may not be eligible to participate.

What data supports the effectiveness of the drug liposomal bupivacaine for postoperative pain control?

Liposomal bupivacaine, which releases the drug over 72 hours, has shown promise in providing longer-lasting pain relief after surgery, potentially reducing the need for opioids and increasing patient satisfaction. However, the evidence is mixed, with some studies suggesting it may not be more effective than standard local anesthetics like unencapsulated bupivacaine or ropivacaine. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for use in humans?

Liposomal bupivacaine (Exparel) has been approved by the FDA for use in surgical site pain relief and has been shown to be safe in various studies, including those involving breast augmentation. However, it is not approved for use in certain areas like the neuraxial space (around the spinal cord), and some studies have examined its safety in off-label uses, such as peripheral nerve blocks. ^{1 6 7 8 9}

How does the drug Ropivacaine Continuous Infusion Catheter, Single Dose Liposomal Bupivacaine differ from other drugs for postoperative pain?

This drug combination is unique because it uses liposomal bupivacaine, which has a longer duration of action compared to regular bupivacaine, reducing the need for additional narcotics and improving patient outcomes after surgery. ^{4 10 11 12 13}

What is the purpose of this trial?

This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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 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 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]

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]

References

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

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine and clinical outcomes. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine For Pain Control. [2018]

5. United States 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

10. United States 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. [2021]

11. United States 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. [2022]

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

Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Surgery: Better Pain Control and Patient Outcomes with Liposomal Bupivacaine than Bupivacaine. [2020]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Timing of Transversus Abdominis Plane Block and Postoperative Pain Management. [2022]