Liposomal Bupivacaine for Postoperative Pain

(SOOOTHE Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Missouri, Kansas City

Must not be taking: Opioids, NSAIDs

Disqualifiers: Opioid use disorder, Cardiovascular disease, Liver disorder, Renal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 7 days

97 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently using opioids or have a history of opioid use disorder, you would not be eligible to participate.

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

Some studies suggest that liposomal bupivacaine may help reduce the need for narcotics and improve recovery times after surgery, such as in laparoscopic colon resections. However, a systematic review found that it often does not provide better pain relief or reduce opioid use compared to other treatments. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for use in humans?

Liposomal bupivacaine has been used safely in various surgeries, such as laparoscopic colorectal surgery, where it helped reduce the need for narcotics and improved recovery times. However, there is a case report of respiratory depression when used with other pain medications, indicating that its safety, especially with other drugs, needs careful consideration. ^{1 2 3 4 6}

What makes liposomal bupivacaine unique for postoperative pain management?

Liposomal bupivacaine is unique because it is a long-acting local anesthetic that releases bupivacaine slowly over time, providing extended pain relief after surgery. This sustained release reduces the need for opioid pain medications, which can have significant side effects. ^{3 7 8 9 10}

What is the purpose of this trial?

As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.

Research Team

Gary Sutkin, MD

Principal Investigator

University of Missouri, Kansas City

Devika Maulik, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

This trial is for women aged 18-45 having a scheduled cesarean delivery, who can communicate in English or with an interpreter. They must be able to do pain assessments and haven't used opioids recently. It's not for those with unscheduled deliveries, opioid use disorder, certain health issues like severe kidney disease, allergies to local anesthetics/NSAIDs, or complications requiring additional surgery.

Inclusion Criteria

Ability to complete numeric pain scale assessment and surveys

I need an interpreter to communicate in English.

I am scheduled for a cesarean delivery without complications.

Exclusion Criteria

Deliveries that were not scheduled in advance.

I have kidney problems or my creatinine level is above 1.1.

You were born before 37 weeks of pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a transversus abdominis plane block with either liposomal bupivacaine or saline during cesarean delivery

7 days

Inpatient stay up to 6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, opioid use, and recovery quality

6 weeks

Postoperative visits at 7 days, 14 days, and 6 weeks

Treatment Details

Interventions

• Deposition of saline
• Liposomal bupivacaine
• TAP block

Trial Overview The study tests if a TAP block using liposomal bupivacaine reduces the need for opioid painkillers after C-sections through day 7 post-op. It's a double-blind trial where patients are randomly assigned to receive either the drug or saline as control without knowing which one they get.

Participant Groups

Group I: Treatment Active Control 2 Interventions

The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right.

Group II: Control Placebo Group 2 Interventions

The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side).

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

Truman Medical Center

Collaborator

Trials

10

Recruited

301,000+

Findings from Research

Transversus abdominis plane (TAP) blocks with liposomal bupivacaine provided pain relief at rest that was non-inferior to epidural analgesia in patients recovering from major abdominal surgery, with a minimal difference in pain scores.

However, patients receiving TAP blocks required more opioids than those with epidurals, but experienced significantly less hypotension, suggesting TAP blocks may be safer for patients at risk of low blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. Turan, A., Cohen, B., Elsharkawy, H., 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]

Liposomal bupivacaine (LB) used in a transversus abdominis plane (TAP) block, either alone or with intrathecal morphine (ITM), resulted in similar opioid consumption compared to ITM alone for pain management after cesarean delivery, indicating its effectiveness as an analgesic option.

Both LB groups experienced significantly less pruritus (itchiness) compared to the ITM group, suggesting that LB may offer a safer profile with fewer side effects in postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. Habib, AS., Nedeljkovic, SS., Horn, JL., et al.[2022]

In a randomized controlled trial involving 57 patients undergoing midurethral sling placement, liposomal bupivacaine resulted in lower median pain scores on postoperative day 1 compared to a mixture of bupivacaine and lidocaine (20 mm vs 30 mm), indicating some efficacy in pain management.

Despite the initial lower pain scores, there were no significant differences in overall opioid and nonsteroidal anti-inflammatory drug consumption or in quality of recovery scores after 7 days, suggesting that liposomal bupivacaine may not provide a clinically significant advantage over traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. Iwanoff, C., Salamon, C.[2020]

References

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

Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. [2022]

2. 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]

3. 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]

4. 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]

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

The Efficacy of Liposomal Bupivacaine for Opioid and Pain Reduction: A Systematic Review of Randomized Clinical Trials. [2021]

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

Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. [2022]

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

Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. [2022]

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

Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. [2020]

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

Are Patients Interested in Liposomal Bupivacaine as a Nonopioid Alternative for Postsurgical Analgesia Following Third Molar Extractions? [2023]

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

The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial. [2022]