A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
Overview
- Phase
- Phase 4
- Intervention
- Exparel
- Conditions
- Postoperative Pain
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
Detailed Description
Study Design: This is a prospective, single-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing bupivacaine liposomal injectable suspension (Exparel®) versus regular bupivacaine hydrochloride (HCl). Procedure: In patients aged 18 and over who require sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions will be screened and consented for potential enrollment. Patients will be randomized following consenting to either Exparel® or regular bupivacaine hydrochloride group. Course of Study: The study will accrue patients over the course of 4 years. Enrollment: Enrollment will consist of all adult patients aged 18 and over undergoing surgical procedures requiring sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions. Patients will be screened and consented preoperatively. If the patient is deemed eligible and consents to participate, randomization will occur and the patient will be considered enrolled. Recruitment: The target for enrollment will be 280 patients (the study target sample size per power analysis, but actual enrollment will be greater (330 patients) to account for exclusions for various reasons in order to achieve the target recruitment). Risks: There is a small increased risk to the patients by participating in the study in addition to a possible chance of breach in patient confidentiality as the study involves evaluation of an FDA-approved drug. As detailed in the informed consent, the subjects are at risk of developing adverse effects from Exparel®, described on the drug packet insert and from HCl Bupivacaine, also described on the drug packet insert. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information. Data Safety Monitoring: As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Additionally, in view of the uncertainty attached to the treatment effects in this heterogeneous population, owing to limited currently available data, an independent Data Safety Monitoring Committee, will oversee the progress of the trial. IND#: The drugs that will be used are already approved by the FDA and do not have IND/IDE# Proposed Funding Source: The study is internally funded and is investigator-initiated. Communication of Study Results: The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.
Investigators
Kristofer Charlton-Ouw
Associate Professor, Department of Cardiothoracic and Vascular Surgery
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •18 years-old or older, and
- •Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
- •There is reasonable expectation that the patient will be extubated within 24 hours after surgery
Exclusion Criteria
- •The patient has a known allergy to morphine or any opioid
- •The patient has a known chronic pain disorder or takes daily opioid medication \> 1 month prior to surgery
- •There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
- •High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.
Arms & Interventions
Exparel®
Patients in this group will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals.
Intervention: Exparel
Exparel®
Patients in this group will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals.
Intervention: Patient Controlled Analgesia (PCA)
Regular Bupivacaine
Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals
Intervention: Bupivacaine hydrochloride
Regular Bupivacaine
Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals
Intervention: Patient Controlled Analgesia (PCA)
Outcomes
Primary Outcomes
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
Time Frame: postoperative day 3
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
Time Frame: postoperative day 3
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
Time Frame: postoperative day 3
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Secondary Outcomes
- Overall Opioid Use(Over the first 72 hours after surgery)
- Mean Length of Hospital Stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Change From Baseline in Quality of Life(Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3)
- Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours(72 hours after surgery)
- Hospital Cost for Patient Care During Hospitalization(duration of hospital stay, an expected average of 4 weeks)