Long-Lasting Pain Relief for Postoperative Pain in Bariatric Surgery

Overseen By David Lanning

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Disqualifiers: Allergy to bupivacaine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates long-lasting pain relief for individuals undergoing bariatric surgery, which addresses severe obesity. It compares two treatments: standard bupivacaine, which eases pain for about 6 hours, and liposomal bupivacaine, a long-acting local anesthetic that may last up to 72 hours. The researchers aim to determine if the longer-lasting version can better manage pain during the critical days after surgery. Individuals undergoing a laparoscopic sleeve gastrectomy at the Children's Hospital of Richmond, without a bupivacaine allergy, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that liposomal bupivacaine, also known as Exparel, is generally safe and well-tolerated. In one study, patients who received liposomal bupivacaine experienced manageable pain, with levels decreasing over several days. Importantly, this research reported no side effects.

Another review found that liposomal bupivacaine was as safe as standard treatments and sometimes more effective for managing post-surgery pain. This formulation is designed to provide pain relief for up to 72 hours, longer than traditional bupivacaine.

Overall, previous studies have demonstrated a good safety record for liposomal bupivacaine. For those considering participation, this evidence suggests it is a promising option for managing post-surgery pain with minimal risk of side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about liposomal bupivacaine because it offers a potentially longer-lasting solution for managing postoperative pain in bariatric surgery. Unlike standard bupivacaine, which provides short-term relief, liposomal bupivacaine is designed to release the anesthetic slowly over time, extending pain relief duration. This extended-release mechanism can lead to less frequent dosing and possibly reduce the need for opioid pain medications, which is a significant advantage in managing postoperative recovery.

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

Research has shown that liposomal bupivacaine, which participants in this trial may receive, can relieve pain longer than regular bupivacaine. Studies have found it significantly reduces pain 24, 48, and 72 hours after surgery. Additionally, patients using liposomal bupivacaine often require fewer opioids for pain management post-surgery. Specifically, one study found that 41.3% of patients didn't need any narcotics at home. This suggests that liposomal bupivacaine could be a more effective way to manage post-surgical pain. Meanwhile, another group in this trial will receive standard bupivacaine as the active comparator. ^{6 7 8 9 10}

Who Is on the Research Team?

Jason Sulkowski

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for teens (13-2018 years old) with severe obesity undergoing laparoscopic sleeve gastrectomy at the Children's Hospital of Richmond at VCU. Participants must understand English or Spanish and not have allergies to bupivacaine.

Inclusion Criteria

Only patients treated at the Children's Hospital of Richmond at VCU will be included

Exclusion Criteria

I am having other surgeries in addition to the sleeve gastrectomy.

I am proficient in English or Spanish.

This criterion seems to contain a typo regarding age.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo bariatric surgery and receive either standard bupivacaine or liposomal bupivacaine for pain control

1 day

In-patient hospital stay

Post-operative Monitoring

Participants' pain scores and opioid use are monitored on post-operative days 0, 1, 2, and 3

4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Bupivacaine
• Standard Bupivacaine

Trial Overview

The study compares liposomal bupivacaine, which may control pain up to 72 hours, with standard bupivacaine that works up to 6 hours. It aims to see if the longer-lasting formula better matches the time when post-surgery pain is highest.

How Is the Trial Designed?

Group I: Experiemental Experimental Treatment 1 Intervention

Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery.

Group II: Standard of Care Active Control 1 Intervention

Subjects will be treated with standard bupivacaine after undergoing bariatric surgery.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

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 study of 90 patients undergoing immediate breast reconstruction, the use of liposomal bupivacaine (LB) significantly reduced postoperative pain scores compared to traditional pain management methods, indicating its efficacy as a pain reliever.

Patients receiving LB also had a shorter hospital stay (1.5 days) compared to those on narcotics (2.0 days), with no reported adverse events, highlighting its safety and potential benefits in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Butz, DR., Shenaq, DS., Rundell, VL., et al.[2022]

Liposomal bupivacaine significantly reduced postoperative pain and the need for antiemetics in certain obesity classes, particularly showing lower pain scores immediately after surgery and at discharge for obesity class I patients.

Patients receiving liposomal bupivacaine had shorter hospital stays, especially among premenopausal women, indicating potential benefits in recovery time and overall patient outcomes compared to standard bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. Kalaria, SS., Boukovalas, S., Padilla, PL., et al.[2019]

In a study of 100 patients undergoing weight loss surgery, liposomal bupivacaine did not significantly reduce postoperative opioid use compared to plain bupivacaine, indicating it may not be effective for minimizing opioid consumption in this context.

However, the implementation of an enhanced recovery after surgery (ERAS) program was associated with a significant reduction in opioid use, suggesting that ERAS protocols may be more beneficial for managing pain and reducing opioid reliance post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine Decrease Postoperative Opioid Use in Conjunction with an Enhanced Recovery After Bariatric Surgery Pathway? A Prospective, Double-blind, Randomized Controlled Trial. Becker, E., Hernandez, A., Greene, H., et al.[2023]

In a study of 61 patients undergoing laparotomy, the use of sustained release liposomal bupivacaine (LB) significantly reduced opioid consumption in the first 72 hours post-surgery, with the MMT + LB group using 78 mg of morphine compared to 112 mg in the control group.

Patients receiving LB also experienced a faster recovery, with a decrease in time to flatus by 1.0 days, indicating that LB can enhance post-operative recovery and should be considered for pain management after laparotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine reduces narcotic use and time to flatus in a retrospective cohort of patients who underwent laparotomy. Burnett, A., Faley, B., Nyirenda, T., et al.[2019]

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

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]

In a study involving 231 patients undergoing laparoscopic bariatric surgery, liposomal bupivacaine (LB) did not significantly reduce postoperative opioid use compared to standard bupivacaine, indicating similar efficacy in pain management.

Interestingly, a higher percentage of patients in the standard bupivacaine group reported not needing any narcotics at home during the first few days after surgery, suggesting that multimodal pain management strategies may be more effective than relying solely on the type of anesthetic used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of liposomal bupivacaine versus bupivacaine in port site injections on postoperative pain within enhanced recovery after bariatric surgery program: a randomized clinical trial. Ma, P., Lloyd, A., McGrath, M., et al.[2020]

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