Clinical trial

Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

ID

Name

202305284

Description

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. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.

Trial arms

Trial start

2024-01-01

Estimated PCD

2024-09-30

Trial end

2025-03-31

Status

Recruiting

Phase

Early phase I

Treatment

Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

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

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Blood Test

Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

3D CAM Delirium Severity Scoring

Questionnaire that will rate each symptom of delirium

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Generalized Anxiety Disorder 7-item (GAD-7) scale

Questionnaire for screening and severity measurement of generalized anxiety disorder.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Numerical Rating Score (NRS)

Questionnaire assessing pain intensity

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

PROMIS-Pain Interference

Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Oswestry Disability Index (ODI)

Questionnaire assessing disability and quality of life impairment in adults with lower back pain.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Saint Louis University Mental Status Examination (SLUMs)

Questionnaire assessing baseline cognition.

Arms:

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 Rating Scale-Revised-98 (DRS)

16 item clinician rated scale assessing delirium severity.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Telephone Interview for Cognitive Status - Modified (TICS-M)

Telephone interview questionnaire evaluating patient cognitive status.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

The amount of opioids administered will be collected through patient self-report

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Patient Health Questionnaire depression scale (PHQ-8)

Questionnaire used to diagnose and determine the severity measure for depressive disorders.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Pain Catastrophizing

Scale used to determine pain catastrophizing and it's severity.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Fear Avoidance Beliefs Questionnaire (FABQ)

Questionnaire used to help predict patients that have a high pain avoidance behavior.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Opioid Side Effects and Likeability Questionnaire

Survey determining adverse events related to opioid side effects and complications.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Daily Pain Trajectory

Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Tampa Scale of Kinesiophobia

Questionnaire assessing Kinesiophobia

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Quality of Recovery 15

Questionnaire assessing postoperative quality of recovery

Arms:

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Size

50

Primary endpoint

Numerical Rating Score

Change assessed from pre-surgery to 12 weeks post-operatively.

Daily Pain Trajectory

Change assessed from 1 day to 30 days post-operatively

Pain Catastrophizing

Change from Pre-operation score to 12 weeks post-operatively

Pain Fear and Avoidance

Change from Pre-operation score to 12 weeks post-operatively

Pain Interference

Change from Pre-operation score to 12 weeks post-operatively

Generalized Anxiety Disorder

Change from pre-operation score to 12 weeks post-operatively

Personal Health Questionnaire Depression Scale

Change from pre-operation score to 12 weeks post-operatively

Oswestry disability index

Change from Pre-operative score to 12 weeks post-operatively

Tampa Scale of Kinesiophobia

Change from Pre-operative score to 12 weeks post-operatively

Delirium Rating Scale-Revised-98

Change from Pre-operative score to 12 weeks post-operatively

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

Change from Pre-operative score to 12 weeks post-operatively

Modified Telephone Interview of Cognitive Status

Change from Pre-operative score to 12 weeks post-operatively

Saint Louis University Mental Status Examination (SLUMs)

Change from Pre-operative score to 12 weeks post-operatively.

Eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both patient (participant) and surgeon will be masked', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-05-09

1 organization

Organization

University of Iowa