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PAIN - Postoperative Analgesia INvestigation (PAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111746
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Exparel Drug: Bupivacaine hydrochloride Drug: Patient Controlled Analgesia (PCA) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
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.
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
Actual Study Start Date : November 20, 2013
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: bupivacaine liposomal injectable suspension (Exparel®)

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

Active Comparator: 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
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.
Other Name: Regular Bupivacaine

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




Primary Outcome Measures :
  1. Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) [ Time Frame: postoperative day 1 ]
    The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  2. Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) [ Time Frame: postoperative day 2 ]
    The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  3. Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) [ Time Frame: postoperative day 3 ]
    The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  4. Postoperative Pain as Assessed by a Five-point Satisfaction Scale [ Time Frame: postoperative day 1 ]
    The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  5. Postoperative Pain as Assessed by a Five-point Satisfaction Scale [ Time Frame: postoperative day 2 ]
    The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  6. Postoperative Pain as Assessed by a Five-point Satisfaction Scale [ Time Frame: postoperative day 3 ]
    The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  7. Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) [ Time Frame: postoperative day 1 ]
    The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").

  8. Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) [ Time Frame: postoperative day 2 ]
    The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").

  9. Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) [ Time Frame: postoperative day 3 ]
    The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").


Secondary Outcome Measures :
  1. Overall Opioid Use [ Time Frame: Over the first 72 hours after surgery ]
    The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed.

  2. Mean Length of Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Indirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost

  3. Change From Baseline in Quality of Life [ Time Frame: Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3 ]
    The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life.

  4. Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours [ Time Frame: 72 hours after surgery ]
  5. Hospital Cost for Patient Care During Hospitalization [ Time Frame: duration of hospital stay, an expected average of 4 weeks ]
    Hospital cost for patient care during hospitalization will be estimated from hospital charges and financial records.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111746


Locations
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United States, Texas
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Kristofer M Charlton-Ouw, MD FACS University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston
  Study Documents (Full-Text)

Documents provided by Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston:
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Responsible Party: Kristofer Charlton-Ouw, Associate Professor, Department of Cardiothoracic and Vascular Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02111746    
Obsolete Identifiers: NCT02474472
Other Study ID Numbers: CTVS-KC02
HSC-MS-13-0620 ( Other Identifier: UTHSC IRB )
First Posted: April 11, 2014    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston:
Postoperative pain
sternotomy
laparotomy
thoracotomy
mini-thoracotomy
truncal surgical incisions
local anaesthetics
bupivacaine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents