Infusion Pump for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of two different pain treatments following surgeries such as ACL reconstruction or shoulder repairs. One group will receive a continuous pain medicine infusion through a pump after surgery, while the other group will receive a single dose of a special pain-relieving drug, 1.3% liposomal bupivacaine (Exparel), before surgery. The study will assess which method reduces pain more effectively and whether patients require less pain medication afterward. Individuals who have undergone surgeries like ACL reconstructions or shoulder repairs and are not allergic to the medications used may be suitable candidates for this trial. As a Phase 4 trial, this study involves treatments that are already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are using chronic opioids or have a history of drug or alcohol abuse, you may not be eligible to participate.
What is the safety track record for these treatments?
Research has shown that ropivacaine, administered via a pump for post-surgery pain relief, is generally safe. In studies involving 382 patients, it was well-tolerated for pain relief after abdominal surgeries. Even at high doses over 24 hours, adults experienced no major issues.
Liposomal bupivacaine, known as Exparel, has received FDA approval for pain management in other surgeries, which supports its safety. However, discussing potential side effects with healthcare providers is important.
Both treatments have been used safely in similar contexts, suggesting they are safe for those considering participation in this trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for postoperative pain because they offer innovative approaches to pain management. The use of continuous ropivacaine via an Ambit pump allows for a steady, controlled release of anesthetic, which could lead to more consistent pain relief compared to traditional single-dose injections. Additionally, liposomal bupivacaine (Exparel) is administered pre-operatively and is designed to release the anesthetic slowly over time, potentially extending the duration of pain relief and reducing the need for additional pain medication. These methods aim to enhance patient comfort and recovery following surgery by providing more effective and sustained pain control.
What evidence suggests that this trial's treatments could be effective for postoperative pain?
Research has shown that ropivacaine 0.2%, administered post-operatively via an Ambit pump in this trial, effectively eases pain after surgery. It is well tolerated and works effectively when delivered through a pump. Studies indicate that ropivacaine 0.2% provides pain relief comparable to stronger doses, making it a suitable option for post-surgical use.
In another arm of this trial, liposomal bupivacaine, administered pre-operatively, manages pain effectively with a single shot before surgery. It releases the medication slowly, offering long-lasting pain relief after the operation. Both treatments have proven effective for post-surgical pain, with liposomal bupivacaine providing extended relief from a single dose and ropivacaine offering continuous relief through a pump.16789Are You a Good Fit for This Trial?
This trial is for adults over 18 who are undergoing specific surgeries like ACL reconstruction, shoulder labrum or rotator cuff surgery, and certain knee operations at the University Center for Ambulatory Surgery. Participants must be interested in joining and able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Operative
A single-shot of Liposomal Bupivacaine (Exparel) will be administered pre-operatively
Post-Operative
Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 1.3% liposomal bupivacaine (Exparel)
- Bupivacaine 0.5% Injectable Solution
- Ropivacaine 0.2% Injectable Solution
Trial Overview
The study compares two pain management methods after surgery: a postoperative infusion pump delivering local anesthetics directly to the surgical site versus a preoperative nerve block. The goal is to see which method better reduces pain scores and lessens the need for painkillers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders).
A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
Ropivacaine: A review of its pharmacology and clinical use
Ropivacaine is a well tolerated regional anaesthetic effective for surgical anaesthesia as well as the relief of postoperative and labour pain.
Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ...
Ropivacaine 0.2% and 0.4% were associated with similar levels of postoperative pain, supplemental ropivacaine bolus demands, and supplemental opioid ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT02959476?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22BioQ%20Pharma,%20Inc.%22))&rank=1Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment ...
This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of post-surgical pain in patients undergoing Cesarean delivery. Half of the ...
Comparing the effectiveness of ropivacaine 0.5% versus ...
In this study we found that ropivacaine 0.2% was as effective as ropivacaine 0.5% in providing postoperative analgesia; however, intraoperatively, we found that ...
Naropin® (ropivacaine HCl) Injection - accessdata.fda.gov
There were 8 clinical studies performed in 382 patients to evaluate Naropin 2 mg/mL. (0.2%) for postoperative pain management after upper and lower abdominal ...
Ropivacaine: Uses, Interactions, Mechanism of Action
Ropivacaine is an amide-type local anesthetic used for local or regional anesthesia during surgery and for short-term management of acute pain.
DATA SHEET
Cumulative doses up to 800 mg ropivacaine for surgery and post operative analgesia administered over 24 hours were well tolerated in adults, as were ...
ROPIVACAINE HYDROCHLORIDE INJECTION
ROPIVACAINE HYDROCHLORIDE INJECTION should be administered at the smallest dose and the lowest concentration which are consistent with the ...
Summary of Product Characteristics
A single caudal epidural injection of ropivacaine 2 mg/ml produces adequate postoperative analgesia below T12 in the majority of patients when a ...
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