Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03745040
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Twin Cities Spine Center
Information provided by (Responsible Party):
Allina Health System

Brief Summary:
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Lumbar Disc Herniation Lumbar Disc Disease Lumbar Spondylolisthesis Drug: Liposomal bupivacaine Phase 4

Detailed Description:
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective randomized clinical trial with two cohorts: one experimental and one control.
Masking: Single (Participant)
Masking Description: Subjects will be blinded and will not be informed if they received the study drug or not.
Primary Purpose: Treatment
Official Title: Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
Actual Study Start Date : January 26, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Exparel

Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL).

Frequency: Single intraoperative administration

Drug: Liposomal bupivacaine
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
Other Name: Exparel

No Intervention: Group B: No Exparel
Standard of Care



Primary Outcome Measures :
  1. Change in Visual Analog Pain Scores [ Time Frame: Through study completion, an average of 2.5 days ]
    Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10).


Secondary Outcome Measures :
  1. Number of Participants with Pain [ Time Frame: Through study completion, an average of 2.5 days ]
    Proportion of pain free subjects, an average of 2.5 days

  2. Discomfort [ Time Frame: Through study completion, an average of 2.5 days ]
    Overall Benefit of Analgesia Score. Respondents complete seven questions, each with a score of 0 (minimal or not at all) to 4 (maximum or very much); the total OBAS ranges between 0 (complete relief of pain) and 28 (no benefit).

  3. Total Opioid Consumption [ Time Frame: Through study completion, an average of 2.5 days ]
    Total postsurgical opioid consumption in morphine equivalents

  4. Number of Opioid-related Adverse Events [ Time Frame: Through study completion, an average of 2.5 days ]
    Average number of opioid-related adverse events per patient

  5. Patient Cost of In-Hospital Stay [ Time Frame: Through study completion, an average of 2.5 days ]
    Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy

  6. Length of Stay [ Time Frame: Through study completion, an average of 2.5 days ]
    Number of days in the hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease
  • Receives open, one-level posterior spinal fusion

Exclusion Criteria:

  • Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
  • Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.
  • Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.
  • Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow
  • Is less than 18 years old.
  • Is pregnant.
  • Cannot read and speak English.

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): NCT03745040


Contacts
Layout table for location contacts
Contact: John M Dawson, PhD 612-775-6233 jmdawson@tcspine.com
Contact: Berit A Swanberg 612-773-6182 baswanberg@tcspine.com

Locations
Layout table for location information
United States, Minnesota
Abbott Northwestern Hospital, Allina Health System Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: John M Dawson, PhD    612-775-6233    jmdawson@tcspine.com   
Contact: Berit A Swanberg    612-775-6182    baswanberg@tcspine.com   
United Hospital, Allina Health System Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: John M Dawson, PhD    612-775-6233    jmdawson@tcspine.com   
Contact: Berit A Swanberg    612-775-6182    baswanberg@tcspine.com   
Sponsors and Collaborators
Allina Health System
Twin Cities Spine Center
Investigators
Layout table for investigator information
Principal Investigator: Christopher Alcala-Marquez, MD Allina Health System
  Study Documents (Full-Text)

Documents provided by Allina Health System:

Publications:

Layout table for additonal information
Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT03745040     History of Changes
Other Study ID Numbers: 1252230
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents