PAIN - Postoperative Analgesia INvestigation

PHASE4CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

November 20, 2013

Primary Completion Date

May 3, 2017

Study Completion Date

June 30, 2017

Conditions
Postoperative Pain
Interventions
DRUG

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.

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.

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

Trial Locations (1)

77030

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

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER

NCT02111746 - PAIN - Postoperative Analgesia INvestigation | Biotech Hunter | Biotech Hunter