TAP Blocks with Ropivacaine vs Liposomal Bupivacaine for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of California, Davis
Must not be taking: Opioids, Anticoagulants
Disqualifiers: Pregnancy, Prisoners, Hypersensitivity, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.12345
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.16789
How does the drug Ropivacaine Continuous Infusion Catheter, Single Dose Liposomal Bupivacaine differ from other drugs for postoperative pain?
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.
I am 18 years old or older.
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.
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Trial 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 (Local Anesthetic)
- Single Dose Liposomal Bupivicaine (Local Anesthetic)
Trial OverviewThe 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
2Treatment groups
Active Control
Group I: Ropivacaine Continuous Infusion CatheterActive Control1 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 bupivicaineActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California DavisSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
References
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 and clinical outcomes. [2022]In the multimodal approach to the management of postoperative pain, local infiltration and regional blocks have been increasingly utilized for pain control. One of the limitations of local anesthetics in the postoperative setting is its relatively short duration of action. Multivesicular liposomes containing bupivacaine have been increasingly utilized for their increased duration of action. Compared with bupivacaine HCl, local infiltration of liposomal bupivacaine has shown to have an increase in duration of action and causes delay in peak plasma concentration. In this article, we attempt to review the clinical literature surrounding liposomal bupivacaine and its evolving role in perioperative analgesia. This new bupivacaine formation may have promising implications in postoperative pain control, resulting in increased patient satisfaction and a decrease in both hospital stay and opioid-induced adverse events (AEs). Although more studies are needed, the preliminary clinical trials suggest that liposomal bupivacaine has predictable pharmacokinetics, a similar side effect profile compared with bupivacaine HCl, and is effective in providing increased postoperative pain control.
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]Liposomal bupivacaine (LB) is a depot formulation of bupivacaine, which releases the drug over 72 hours to prolong local pain control. This retrospective study compares the effect of using LB versus plain bupivacaine on postoperative pain control, length of hospital stay and cost among patients undergoing vaginal reconstructive surgery.
Bupivacaine Versus Liposomal Bupivacaine For Pain Control. [2018]Local infiltrations and regional blocks have been some of the effective ways employed to manage and control post-operative pain. One of the limitations of administration of local anesthesia drugs in post-operative conditions is its inability to act for a longer period of time. Multi-vesicular liposomes made up of bupivacaine have been progressively used for their increased duration of action. Compared to bupivacaine HCL, local infiltration of liposomal bupivacaine have shown to have a significantly increase the duration and delay in peak plasma concentration. In this article, we attempt to compare liposomal bupivacaine and bupivacaine based on available clinical literatures. Liposomal bupivacaine has been demonstrated to have promising implications in post- operative pain control resulting in increased patient satisfaction; reduced hospital admission and opioid induced adverse events. Clinical studies have identified liposomal bupivacaine to be effective in delivering increased post-operative pain control. The purpose of this review is to give a comprehensive comparison between bupivacaine liposomal and conventional bupivacaine based on reported clinical trials.
Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial. [2021]Liposomal bupivacaine (LB), as an extended-release local anesthetic, may provide lasting pain control and therefore decrease the need for narcotics in the immediate postoperative period.
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
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.
Delayed Respiratory Depression Secondary to Opioid Overdose After Multimodal Analgesia With Transversus Abdominis Plane Blocks in Postanesthesia Care Unit: A Case Report. [2021]Pain control after open abdominal surgery often includes multimodal analgesia with thoracic epidural or transversus abdominis plane (TAP) block. After liposomal bupivacaine was approved for TAP blocks in 2015, it became an alternative to indwelling catheters. However, the pharmacokinetics and safety of its use during the perioperative period have not been thoroughly investigated, especially in conjunction with parenteral opioids. We present a case report of an elderly patient having urgent laparoscopic converted to open abdominal surgery, who experienced postoperative respiratory depression in the recovery room after multimodal therapy with liposomal bupivacaine TAP blocks, intravenous (IV) opioids, and ketorolac.
Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. [2022]Optimal pain control after major surgery contributes to a patient's recovery and satisfaction. The use of liposomal bupivacaine in subcostal transversus abdominis plane (TAP) blocks for postoperative pain control after robot assisted abdominal surgery has yet to be studied.
Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Surgery: Better Pain Control and Patient Outcomes with Liposomal Bupivacaine than Bupivacaine. [2020]Transversus abdominis plane (TAP) blocks are a safe and effective way to provide immediate postoperative pain relief in surgical patients, and have been shown to decrease narcotic requirements. Concerns about complications of narcotics, increase in hospital length of stay (LOS), and health-care costs make this of particular interest. We compared standard bupivacaine TAP blocks with those carried out using liposomal bupivacaine to evaluate postoperative outcomes. Fifty patients undergoing elective laparoscopic colectomy received laparoscopic liposomal bupivacaine TAP blocks using 80 cc of local anesthetic, and data were collected prospectively during hospitalization. Data collected included amount of narcotic medication used during hospitalization, number of days to ambulation, number of days to bowel function, and LOS. These patients were compared with the last 50 patients recruited to the control/bupivacaine TAP block arm of the study. The same data parameters were collected and all patients were on an enhanced recovery protocol, which included scheduled acetaminophen, ibuprofen, and gabapentin by mouth, as well as clear liquid diet starting on postoperative day zero. Statistical analysis was performed using Student's t test and Fisher's exact test; P < 0.05 was considered statistically significant. Patients treated with liposomal bupivacaine needed less narcotics (5.06 vs 18.75 mg, P = 0.0002), had earlier bowel function (1.7 vs 2.4 days, P = 0.0002), and shorter LOS (2.7 vs 3.4 days, P = 0.0146). Patients undergoing laparoscopic colon resections seem to require fewer narcotics and have better patient outcomes with liposomal bupivacaine TAP blocks. Based on our data, liposomal bupivacaine seems to be superior to bupivacaine for TAP blocks.
Timing of Transversus Abdominis Plane Block and Postoperative Pain Management. [2022]Transversus abdominis plane (TAP) blocks using liposomal bupivacaine can reduce postoperative pain and opioid consumption after surgery. The impact of timing of administration of such blocks has not been determined.