NCT04865211

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 5, 2021

Last Update Submit

April 26, 2021

Conditions

Pain, Postoperative

Keywords

thoracolumbarspinepainpostoperative

Outcome Measures

Primary Outcomes (2)

  • 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

    24-48 hours

  • Total postoperative opioid requirements

    Using daily MME

    1-5 days

Secondary Outcomes (2)

  • Time to Ambulation

    1-5 days

  • Length of Hospital Stay

    1-5 days

Study Arms (3)

Liposomal Bupivicaine

EXPERIMENTAL

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

Drug: Liposomal bupivacaine

Bupivicane

ACTIVE COMPARATOR

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

Drug: Bupivacaine Injection

Placebo

PLACEBO COMPARATOR

Saline injection with 40mL preservative-free saline

Drug: Placebo

Interventions

Liposomal bupivacaineDRUG

Use of liposomal bupivicaine as intraoperative local anesthesia

Liposomal Bupivicaine
Bupivacaine InjectionDRUG

Use of bupivicaine as intraoperative local anesthesia

Bupivicane
PlaceboDRUG

Use of saline as placebo for local anesthesia

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23392233BACKGROUND

  • 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.

    PMID: 31029989BACKGROUND

  • 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.

    PMID: 31681518BACKGROUND

  • 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.

    PMID: 26149600BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Christopher Bilbao, DO

CONTACT

856-968-7965bilbao-christopher@cooperhealth.edu

Patricia Feineigle, PhD

CONTACT

856-342-2363feineigle-patricia@cooperhealth.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 29, 2021

Study Start

April 5, 2021

Primary Completion

February 17, 2022

Study Completion

April 30, 2022

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)