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Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Primary Purpose

Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Disc Disease

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liposomal bupivacaine

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Abbott Northwestern Hospital, Allina Health SystemRecruiting
United Hospital, Allina Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A: Exparel

Group B: No Exparel

Arm Description

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

Standard of Care

Outcomes

Primary Outcome Measures

Change in Visual Analog Pain Scores

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

Number of Participants with Pain

Proportion of pain free subjects, an average of 2.5 days

Discomfort

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).

Total Opioid Consumption

Total postsurgical opioid consumption in morphine equivalents

Number of Opioid-related Adverse Events

Average number of opioid-related adverse events per patient

Patient Cost of In-Hospital Stay

Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy

Length of Stay

Number of days in the hospital

Full Information

NCT ID

NCT03745040

First Posted

November 5, 2018

Last Updated

March 21, 2023

Sponsor

Allina Health System

Collaborators

Twin Cities Spine Center

1. Study Identification

Unique Protocol Identification Number

NCT03745040

Brief Title

Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Official Title

Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allina Health System

Collaborators

Twin Cities Spine Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Disc Disease, Lumbar Spondylolisthesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

This is a prospective randomized clinical trial with two cohorts: one experimental and one control.

Masking

Participant

Masking Description

Subjects will be blinded and will not be informed if they received the study drug or not.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Exparel

Arm Type

Experimental

Arm Description

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

Arm Title

Group B: No Exparel

Arm Type

No Intervention

Arm Description

Standard of Care

Intervention Type

Drug

Intervention Name(s)

Liposomal bupivacaine

Other Intervention Name(s)

Exparel

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Visual Analog Pain Scores

Description

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).

Time Frame

Through study completion, an average of 2.5 days

Secondary Outcome Measure Information:

Title

Number of Participants with Pain

Description

Proportion of pain free subjects, an average of 2.5 days

Time Frame

Through study completion, an average of 2.5 days

Title

Discomfort

Description

Time Frame

Through study completion, an average of 2.5 days

Title

Total Opioid Consumption

Description

Total postsurgical opioid consumption in morphine equivalents

Time Frame

Through study completion, an average of 2.5 days

Title

Number of Opioid-related Adverse Events

Description

Average number of opioid-related adverse events per patient

Time Frame

Through study completion, an average of 2.5 days

Title

Patient Cost of In-Hospital Stay

Description

Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy

Time Frame

Through study completion, an average of 2.5 days

Title

Length of Stay

Description

Number of days in the hospital

Time Frame

Through study completion, an average of 2.5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John M Dawson, PhD

Phone

612-775-6233

jmdawson@tcspine.com

First Name & Middle Initial & Last Name or Official Title & Degree

Berit A Swanberg

Phone

612-773-6182

baswanberg@tcspine.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Alcala-Marquez, MD

Organizational Affiliation

Allina Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abbott Northwestern Hospital, Allina Health System

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John M Dawson, PhD

Phone

612-775-6233

jmdawson@tcspine.com

First Name & Middle Initial & Last Name & Degree

Berit A Swanberg

Phone

612-775-6182

baswanberg@tcspine.com

Facility Name

United Hospital, Allina Health System

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John M Dawson, PhD

Phone

612-775-6233

jmdawson@tcspine.com

First Name & Middle Initial & Last Name & Degree

Berit A Swanberg

Phone

612-775-6182

baswanberg@tcspine.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

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Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

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