PAIN - Postoperative Analgesia INvestigation
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Exparel; Bupivacaine hydrochloride; Patient Controlled Analgesia (PCA)
Intervention description: 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.; 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.; 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 MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design
Masking: Double (Participant, Investigator)
Masking description: Masking included all patients, who were blinded to the contents of the intraoperative injection, as well as partial blinding of the surgical team who were masked from the treatment allocation up until the time of injection following which the knowledge of drug was inevitable as Exparel® has a milky appearance as opposed to the colorless bupivacaine hydrochloride (standard) formulations.
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative pain; sternotomy; laparotomy; thoracotomy; mini-thoracotomy; truncal surgical incisions; local anaesthetics; bupivacaine

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.
    

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.