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Thoracolumbar Block for Spinal Fusion Recovery

Q: Is this research study open to all participants, or are there eligibility requirements?

This medical trial is seeking 50 individuals with delirium between the ages of 65 and 105 to be accepted.

Q: Are there still vacancies available for participation in this research project?

According to information hosted on clinicaltrials.gov, this particular medical study is no longer recruiting patients. Initially posted September 1st 2023 and lastly edited November 15th 2022, individuals who were hoping to take part are out of luck - though 465 other trials remain open for recruitment at the current moment in time.

Q: Does the experimental protocol for this clinical study permit those aged over 50 to enroll?

In order to be accepted into this trial, potential participants must have been born between 1965-2005. The data suggests that 26 trials are recruiting children and youth below the age of 18 whereas 388 studies seek out seniors 65 years old or older.

Q: What aims are being pursued through this clinical investigation?

The primary goal of this trial, assessed over a 12-week period post-operatively, is to measure the Personal Health Questionnaire <a href="https://www.withpower.com/clinical-trials/depression">Depression</a> Scale. Additional measures include the Opioid Side Effects and Likability Questionnaire (measured 1 week and 4 weeks after surgery), Self-reported Adverse Events (collected pre-surgery and at intervals up to 12 weeks following operation) as well as Disposition to Skilled Facilities (recorded in electronic health records).

Phase < 1

Waitlist Available

Led By Catherine R Olinger, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing elective surgery

Indicated for lumbar spinal fusion of less than or equal to 3 levels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 16 months

Awards & highlights

Study Summary

This trial is testing whether a pain-relieving block can help older adults who are having spinal surgery.

Who is the study for?

This trial is for adults aged 65 or older who need lumbar spinal fusion surgery of up to three levels and have no severe heart, lung diseases, cognitive dysfunction, or allergies to local anesthetics. It's not for those with major liver/kidney issues, opioid tolerance, other chronic pain conditions, significant neurological deficits, psychiatric illnesses, under age 65, pregnant/breastfeeding women or those with a high BMI.Check my eligibility

What is being tested?

The study tests the effectiveness of TLIP blocks using bupivacaine anesthesia in reducing post-operative pain and improving recovery in older adults after spinal fusion. It aims to assess feasibility for a larger trial by looking at recruitment rates and patient feedback on this pain management technique.See study design

What are the potential side effects?

Potential side effects from the TLIP block may include localized numbness or weakness due to the anesthesia (bupivacaine), allergic reactions to medication used during the procedure and possible discomfort at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a planned surgery.

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I am recommended to have a spinal fusion surgery for up to 3 spine levels.

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I do not have serious heart or lung conditions.

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I am 65 years old or older.

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I am not allergic to local anesthetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3D-CAM-S and 3D-CAM-ICU

Daily Pain Trajectory

Delirium Rating Scale-Revised-98

+10 more

Secondary outcome measures

90-day Readmission Rates

Blood test for Inflammation

Disposition to skilled-facilities

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineExperimental Treatment18 Interventions

Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Group II: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Active Control17 Interventions

Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Test

2010

N/A

~320

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,452 Total Patients Enrolled

1 Trials studying Delirium

8,100 Patients Enrolled for Delirium

Catherine R Olinger, MDPrincipal InvestigatorClinical Assistant Professor

Media Library

Pain Catastrophizing Clinical Trial Eligibility Overview. Trial Name: NCT05461092 — Phase < 1

Delirium Research Study Groups: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Delirium Clinical Trial 2023: Pain Catastrophizing Highlights & Side Effects. Trial Name: NCT05461092 — Phase < 1

Pain Catastrophizing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05461092 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study open to all participants, or are there eligibility requirements?

"This medical trial is seeking 50 individuals with delirium between the ages of 65 and 105 to be accepted."

Answered by AI

Are there still vacancies available for participation in this research project?

"According to information hosted on clinicaltrials.gov, this particular medical study is no longer recruiting patients. Initially posted September 1st 2023 and lastly edited November 15th 2022, individuals who were hoping to take part are out of luck - though 465 other trials remain open for recruitment at the current moment in time."

Answered by AI

Does the experimental protocol for this clinical study permit those aged over 50 to enroll?

"In order to be accepted into this trial, potential participants must have been born between 1965-2005. The data suggests that 26 trials are recruiting children and youth below the age of 18 whereas 388 studies seek out seniors 65 years old or older."

Answered by AI

What aims are being pursued through this clinical investigation?

"The primary goal of this trial, assessed over a 12-week period post-operatively, is to measure the Personal Health Questionnaire Depression Scale. Additional measures include the Opioid Side Effects and Likability Questionnaire (measured 1 week and 4 weeks after surgery), Self-reported Adverse Events (collected pre-surgery and at intervals up to 12 weeks following operation) as well as Disposition to Skilled Facilities (recorded in electronic health records)."

Answered by AI

Recent research and studies

Archives of Physical Medicine and RehabilitationJournal

Pain Sensitivity and Pain Catastrophizing Are Associated with Persistent Pain and Disability After Lumbar Spine Surgery

Coronado, Rogelio A., Steven Z. George, Clinton J. Devin, Stephen T. Wegener, and Kristin R. Archer. 2015. “Pain Sensitivity and Pain Catastrophizing Are Associated with Persistent Pain and Disability After Lumbar Spine Surgery”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2015.06.003.

Anesthesia & AnalgesiaJournal

Postoperative Delirium: The Importance of Pain and Pain Management

Vaurio, Linnea E., Laura P. Sands, Yun Wang, E Ann Mullen, and Jacqueline M. Leung. 2006. “Postoperative Delirium: The Importance of Pain and Pain Management”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000199156.59226.af.

Journal of the American Geriatrics SocietyJournal

Delirium After Spine Surgery in Older Adults: Incidence, Risk Factors, and Outcomes

Brown, Charles H., IV, Andrew LaFlam, Laura Max, Julie Wyrobek, Karin J. Neufeld, Khaled M. Kebaish, David B. Cohen, Jeremy D. Walston, Charles W. Hogue, and Lee H. Riley. 2016. “Delirium After Spine Surgery in Older Adults: Incidence, Risk Factors, and Outcomes”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/jgs.14434.

The Journals of Gerontology Series A: Biological Sciences and Medical SciencesJournal