Liposomal Bupivacaine for Post-Surgery Pain in Fibroids
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Prior Safety Data
Trial Summary
What is the purpose of this trial?The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
How is liposomal bupivacaine different from other drugs for post-surgery pain in fibroids?
Liposomal bupivacaine is unique because it is a long-acting form of bupivacaine that is designed to be released slowly over time, providing extended pain relief after surgery. This can potentially reduce the need for additional pain medications, such as opioids, compared to traditional bupivacaine.
235711Is liposomal bupivacaine safe for humans?
Liposomal bupivacaine, also known as Exparel, has been shown to be safe in various surgical settings, including breast augmentation and reduction mammaplasty, based on multiple studies and post-marketing safety reviews.
145812What data supports the effectiveness of the drug liposomal bupivacaine for post-surgery pain in fibroids?
Research shows that liposomal bupivacaine can help reduce pain after surgeries like hysterectomy and cesarean delivery, and it may also lower the need for opioids, which are strong painkillers with side effects. This suggests it could be effective for managing post-surgery pain in fibroid treatments as well.
4691013Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Eligibility Criteria
This trial is for individuals over 50kg who are scheduled for open myomectomy surgery to remove fibroids and do not have a history of allergies to study medications, drug or alcohol abuse, liver disease, severe heart rhythm problems, epilepsy, seizures, or chronic pain other than from myomas.Inclusion Criteria
I weigh more than 50kg and am preparing for open surgery to remove fibroids.
I have no history of drug, alcohol abuse, or liver disease.
I don't have a history of severe heart rhythm problems, epilepsy, seizures, or chronic pain except from fibroids.
Participant Groups
The trial is testing the effectiveness of two types of local anesthetics: liposomal bupivacaine versus standard bupivacaine. Patients will be randomly assigned to receive one of these during their surgery. The main focus is on whether these anesthetics reduce the need for opioid pain relief after surgery.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liposomal bupivacaine TAPExperimental Treatment3 Interventions
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Group II: Bupivacaine TAPPlacebo Group2 Interventions
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]Pooled safety data from 10 randomized, double-blind studies of liposome bupivacaine, a novel local analgesic formulation, were examined.
Bupivacaine liposomal versus bupivacaine: comparative review. [2021]Bupivacaine liposomal injection was recently approved by the US Food and Drug Administration (FDA) as a local anesthetic for use in management of postsurgical pain in adults. When compared to placebo, bupivacaine liposomal decreases postoperative pain and opioid use. This review examines the efficacy of bupivacaine liposomal when compared to conventional bupivacaine ± epinephrine using published and unpublished data provided to the FDA by the manufacturer.
Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]Patients undergoing mastectomy and prosthetic breast reconstruction have significant acute postsurgical pain, routinely mandating inpatient hospitalization. Liposomal bupivacaine (LB) (Exparel; Pacira Pharmaceuticals, Inc., Parsippany, N.J.) has been shown to be a safe and effective pain reliever in the immediate postoperative period and may be advantageous for use in mastectomy and breast reconstruction patients.
The safety of liposome bupivacaine 2 years post-launch: a look back and a look forward. [2022]The need for better post-surgical pain management continues to be unmet, despite clinicians' awareness and concern for many years. Opioids remain the standard of care because of their analgesic efficacy; however, opioid use is often associated with adverse effects and poor patient outcomes. Multimodal analgesic regimens have recently been endorsed as a way to provide adequate post-surgical pain control while reducing opioid consumption. Liposome bupivacaine is a liposomal formulation of bupivacaine indicated for a single administration into the surgical site. Based on the available clinical trial data compiled to date, as well as the author's review of publicly available post-marketing safety information, liposome bupivacaine may be a viable addition to currently available therapeutic options for post-surgical analgesia while reducing potential risks associated with use of opioid analgesics, and may represent a useful addition to the multimodal analgesic modalities currently used for post-operative pain management. The potential for its use in other areas is also being investigated. The purpose of this review is to examine the currently available post-marketing safety information on liposome bupivacaine.
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting.
Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. [2022]To investigate opioid use and pain scores associated with incisional injection of liposomal bupivacaine compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies.
Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. [2018]Liposomal bupivacaine is indicated for administration into the surgical site to produce post-surgical analgesia.
Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]Postoperative pain control can be challenging in reduction mammaplasty patients. This study compares perioperative liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, Inc, San Diego, Calif) with standard local anesthetics to determine if liposomal bupivacaine decreases opioid and antiemetic use, impacting length of stay and complication rates, thus improving patient outcomes.
Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. [2022]To evaluate whether a liposomal bupivacaine incisional block decreases postoperative pain and represents an opioid-minimizing strategy after scheduled cesarean delivery.
Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. [2020]To study the effects of liposomal bupivacaine (LB) compared with bupivacaine hydrochloride with lidocaine on postoperative day 1 pain scores.
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]The authors provide a comprehensive summary of all randomized, controlled trials (n = 76) involving the clinical administration of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, USA) to control postoperative pain that are currently published. When infiltrated surgically and compared with unencapsulated bupivacaine or ropivacaine, only 11% of trials (4 of 36) reported a clinically relevant and statistically significant improvement in the primary outcome favoring liposomal bupivacaine. Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine. Results were mixed for the 16 trials comparing liposomal and unencapsulated bupivacaine, both within peripheral nerve blocks. Overall, of the trials deemed at high risk for bias, 84% (16 of 19) reported statistically significant differences for their primary outcome measure(s) compared with only 14% (4 of 28) of those with a low risk of bias. The preponderance of evidence fails to support the routine use of liposomal bupivacaine over standard local anesthetics.
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]The purpose of this study was to determine if liposomal bupivacaine 1.3% (LB), Exparel (Pacira Pharmaceuticals), is more effective than bupivacaine hydrochloride 0.25% (BH), Marcaine (Hospira), in reducing postoperative pain and opioid consumption in patients undergoing exploratory lingual nerve microsurgery. The investigators hypothesized that patients who received LB would have a greater reduction in acute postoperative pain, and therefore, a reduction in total opioid use over 72 hours postoperatively.
Liposomal Bupivacaine Injection for Analgesia During Minimally Invasive Supracervical Hysterectomy. [2022]To evaluate the efficacy of intracervical injection of liposomal bupivacaine for postoperative pain control among women undergoing minimally invasive supracervical hysterectomy.