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Postoperative Pain | PAIN - Postoperative Analgesia INvestigation

Postoperative Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postoperative Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ExparelParticipants 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.

Drug:Bupivacaine hydrochlorideParticipants 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.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

Regular BupivacainePatients 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

Study Status

Completed

Start Date: November 20, 2013

Completed Date: June 30, 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)

Secondary Outcome: Overall Opioid Use

Study sponsors, principal investigator, and references

Principal Investigator: Kristofer M Charlton-Ouw, MD FACS

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02111746

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