PAIN - Postoperative Analgesia INvestigation

NCT ID: NCT02111746

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-20
• Study Completion Date: 2017-06-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

Patient Controlled Analgesia (PCA)

Intervention Type: DRUG

Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine hydrochloride

Intervention Type: DRUG

Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

Patient Controlled Analgesia (PCA)

Intervention Type: DRUG

Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day

Interventions

Exparel

Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

Intervention Type: DRUG

Bupivacaine hydrochloride

Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

Intervention Type: DRUG

Patient Controlled Analgesia (PCA)

Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposomal injectable suspension (Exparel®); Regular Bupivacaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Kristofer Charlton-Ouw

Associate Professor, Department of Cardiothoracic and Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristofer M Charlton-Ouw, MD FACS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston

Locations

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33724391 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-13-0620

Identifier Type: OTHER

Identifier Source: secondary_id

CTVS-KC02

Identifier Type: -

Identifier Source: org_study_id

NCT02474472

Identifier Type: -

Identifier Source: nct_alias