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Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Injection
Placebo
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring thoracolumbar, spine, pain, postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients undergoing multilevel lumbar spine surgery, age 18-75

Exclusion Criteria:

  • Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy

Sites / Locations

  • Cooper University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Liposomal Bupivicaine

Bupivicane

Placebo

Arm Description

Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine

Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000

Saline injection with 40mL preservative-free saline

Outcomes

Primary Outcome Measures

Reduction in postoperative pain
Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain
Total postoperative opioid requirements
Using daily MME

Secondary Outcome Measures

Time to Ambulation
Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented
Length of Hospital Stay
Number of postoperative days

Full Information

First Posted
April 5, 2021
Last Updated
April 26, 2021
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04865211
Brief Title
Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery
Official Title
Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery
Detailed Description
Patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. Spine surgeons are looking for ways to reduce the pain that you experience. Anesthesiologists have introduced a procedure, called a "TLIP block" to provide pain relief. The block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. This block has been used by other surgeons for other types of surgeries in the past and has been shown to work. To determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
thoracolumbar, spine, pain, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivicaine
Arm Type
Experimental
Arm Description
Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine
Arm Title
Bupivicane
Arm Type
Active Comparator
Arm Description
Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline injection with 40mL preservative-free saline
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
Use of liposomal bupivicaine as intraoperative local anesthesia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
Use of bupivicaine as intraoperative local anesthesia
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Use of saline as placebo for local anesthesia
Primary Outcome Measure Information:
Title
Reduction in postoperative pain
Description
Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain
Time Frame
24-48 hours
Title
Total postoperative opioid requirements
Description
Using daily MME
Time Frame
1-5 days
Secondary Outcome Measure Information:
Title
Time to Ambulation
Description
Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented
Time Frame
1-5 days
Title
Length of Hospital Stay
Description
Number of postoperative days
Time Frame
1-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing multilevel lumbar spine surgery, age 18-75 Exclusion Criteria: Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Bilbao, DO
Phone
856-968-7965
Email
bilbao-christopher@cooperhealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Feineigle, PhD
Phone
856-342-2363
Email
feineigle-patricia@cooperhealth.edu
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Bilbao, DO
Phone
856-968-7965
Email
bilbao-christopher@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Christopher Bilbao, DO
First Name & Middle Initial & Last Name & Degree
Paul Audu, MD
First Name & Middle Initial & Last Name & Degree
Steven Yocom, DO

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23392233
Citation
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Results Reference
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PubMed Identifier
31029989
Citation
Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
Results Reference
background
PubMed Identifier
31681518
Citation
Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.
Results Reference
background
PubMed Identifier
26149600
Citation
Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
Results Reference
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Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery

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