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

9 Participants Needed

Trial Summary

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.

What data supports the idea that Long-Lasting Pain Relief for Postoperative Pain in Bariatric Surgery is an effective treatment?

The available research shows that using liposomal bupivacaine, a long-lasting pain relief drug, can reduce the need for opioids after surgery. This is important because it helps manage pain while minimizing the use of opioids, which can be addictive. In studies involving other surgeries, like lingual nerve microsurgery and vaginal reconstruction, liposomal bupivacaine was found to be more effective than standard bupivacaine in reducing pain and the need for opioids. This suggests that it could be a beneficial option for managing pain after bariatric surgery as well. ^{1 2 3 4 5}

What safety data exists for liposomal bupivacaine in postoperative pain management?

Liposomal bupivacaine (EXPAREL) has been shown to be safe in various surgical settings, including breast augmentation, mastectomy, and pediatric pharyngoplasty. It is reported to decrease postoperative pain and opioid consumption, with studies indicating its safe use in these contexts. ^{1 3 6 7 8}

Is the drug used in the trial 'Long-Lasting Pain Relief for Postoperative Pain in Bariatric Surgery' a promising treatment?

Yes, the drug, liposomal bupivacaine, is promising because it can reduce pain after surgery and decrease the need for opioids, which are strong painkillers. This can help patients recover more comfortably and quickly. ^{1 3 7 8 9}

What is the purpose of this trial?

Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.

Research Team

Jason Sulkowski

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 (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 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]

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]

References

1. Germany 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. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2020]

4. United States 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. [2023]

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

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]

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

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

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

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]

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

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]

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

Liposomal bupivacaine reduces narcotic use and time to flatus in a retrospective cohort of patients who underwent laparotomy. [2019]