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New treatment option for Delirium
Official title Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
ClinicalTrials.gov ID: NCT05461092
What this study is testing
What is Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine?
Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine is an investigational medicine, being studied as a potential treatment for delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Are 65 or older
- Indicated for lumbar spinal fusion of less than or equal to 3 levels
- Undergoing elective surgery
- no contraindications to local anesthetic or procedures
- no severe cardiac or respiratory disease
You likely can't join if
- 64 years old and younger
- emergency treatment
- pathologic fractures
- seeking revision surgery
- major liver or kidney dysfunction
- coexisting hematological disorder or irreversible abnormal coagulation
See the full eligibility criteria
- Are 65 or older
- Indicated for lumbar spinal fusion of less than or equal to 3 levels
- Undergoing elective surgery
- no contraindications to local anesthetic or procedures
- no severe cardiac or respiratory disease
- no preexisting cognitive dysfunction/dementia
- 64 years old and younger
- emergency treatment
- pathologic fractures
- seeking revision surgery
- major liver or kidney dysfunction
- coexisting hematological disorder or irreversible abnormal coagulation
- patients with previous diagnosis of dementia or SLUMS score \<20
- patient unable to communicate/cooperate/language barrier
- BMI\>40
- allergy to study medications
- opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
- other sources of chronic pain like fibromyalgia
- patients with associated significant CNS or respiratory disease (home oxygen requirements)
- incarcerated patients
- psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
- pregnant or breast feeding
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.