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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 - The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 24 hours after surgery - There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion

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:Exparel

Drug:Bupivacaine hydrochlorideStandard/regular bupivacaine hydrochloride

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: Change in Postoperative Pain

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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