PAIN - Postoperative Analgesia INvestigation

NCT02111746 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: CTVS-KC02HSC-MS-13-0620
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; sternotomy; laparotomy; thoracotomy; mini-thoracotomy; truncal surgical incisions; local anaesthetics; bupivacaine

Outcome Measures

Primary Outcomes (9)

• Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)

  The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  postoperative day 1

• Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)

  The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  postoperative day 2

• Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)

  The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").

  postoperative day 3

• Postoperative Pain as Assessed by a Five-point Satisfaction Scale

  The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  postoperative day 1

• Postoperative Pain as Assessed by a Five-point Satisfaction Scale

  The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  postoperative day 2

• Postoperative Pain as Assessed by a Five-point Satisfaction Scale

  The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).

  postoperative day 3

• Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)

  The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").

  postoperative day 1

• Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)

  The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").

  postoperative day 2

• Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)

  The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").

  postoperative day 3

Secondary Outcomes (5)

• Overall Opioid Use

  Over the first 72 hours after surgery

• Mean Length of Hospital Stay

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• Change From Baseline in Quality of Life

  Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3

• Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours

  72 hours after surgery

• Hospital Cost for Patient Care During Hospitalization

  duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Exparel®

EXPERIMENTAL

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; Drug: Patient Controlled Analgesia (PCA)

Regular Bupivacaine

ACTIVE COMPARATOR

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; Drug: Patient Controlled Analgesia (PCA)

Interventions

Exparel DRUG

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.

Also known as: bupivacaine liposomal injectable suspension (Exparel®)

Exparel®

Bupivacaine hydrochloride DRUG

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.

Also known as: Regular Bupivacaine

Regular Bupivacaine

Patient Controlled Analgesia (PCA) DRUG

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

Exparel®; Regular Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.

  PMID: 33724391 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Kristofer M Charlton-Ouw
• Organization: The University of Texas Health Science Center at Houston

Kristofer.CharltonOuw@uth.tmc.edu

(713) 486-5100

Study Officials

• Kristofer M Charlton-Ouw, MD FACS

  University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Cardiothoracic and Vascular Surgery

Model Details: Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 11, 2014
• Study Start: November 20, 2013
• Primary Completion: May 3, 2017
• Study Completion: June 30, 2017
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)