Clinical trial NCT02111746: PAIN - Postoperative Analgesia INvestigation
Official title: A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative pain
sternotomy
laparotomy
thoracotomy
mini-thoracotomy
truncal surgical incisions
local anaesthetics
bupivacaine
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
timeFrame: postoperative day 1
measure: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
timeFrame: postoperative day 2
measure: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
timeFrame: postoperative day 3
measure: Postoperative Pain as Assessed by a Five-point Satisfaction Scale
timeFrame: postoperative day 1
measure: Postoperative Pain as Assessed by a Five-point Satisfaction Scale
timeFrame: postoperative day 2
measure: Postoperative Pain as Assessed by a Five-point Satisfaction Scale
timeFrame: postoperative day 3
measure: Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
timeFrame: postoperative day 1
measure: Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
timeFrame: postoperative day 2
measure: Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
timeFrame: postoperative day 3
Secondary outcomes:
measure: Overall Opioid Use
timeFrame: Over the first 72 hours after surgery
measure: Mean Length of Hospital Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Change From Baseline in Quality of Life
timeFrame: Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3
measure: Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours
timeFrame: 72 hours after surgery
measure: Hospital Cost for Patient Care During Hospitalization
timeFrame: duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
state: Texas
Study officials:
affiliation: University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston
name: Kristofer M Charlton-Ouw, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.