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

University of Iowa

Status and phase: Enrolling; Early Phase 1

Conditions: Thoracolumbar Interfascial Plane Block; Pain, Back; Delirium; Spinal Fusion

Treatments: Other: Fear Avoidance Beliefs Questionnaire (FABQ); Other: Quality of Recovery 15; Other: PROMIS-Pain Interference; Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME); Other: Telephone Interview for Cognitive Status - Modified (TICS-M); Other: Patient Health Questionnaire depression scale (PHQ-8); Other: Tampa Scale of Kinesiophobia; Other: 3D CAM Delirium Severity Scoring; Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Other: Daily Pain Trajectory; Other: Generalized Anxiety Disorder 7-item (GAD-7) scale; Other: Delirium Rating Scale-Revised-98 (DRS); Other: Oswestry Disability Index (ODI); Other: Opioid Side Effects and Likeability Questionnaire; Other: Saint Louis University Mental Status Examination (SLUMs); Diagnostic Test: Blood Test; Other: Numerical Rating Score (NRS); Other: Pain Catastrophizing

Study type: Interventional

Funder types: Other

Identifiers

NCT05461092

202305284

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Other: Pain Catastrophizing

Other: Numerical Rating Score (NRS)

Diagnostic Test: Blood Test

Other: Saint Louis University Mental Status Examination (SLUMs)

Other: Opioid Side Effects and Likeability Questionnaire

Other: Oswestry Disability Index (ODI)

Other: Delirium Rating Scale-Revised-98 (DRS)

Other: Daily Pain Trajectory

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

Other: 3D CAM Delirium Severity Scoring

Other: Tampa Scale of Kinesiophobia

Other: Patient Health Questionnaire depression scale (PHQ-8)

Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

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

Other: PROMIS-Pain Interference

Other: Quality of Recovery 15

Other: Fear Avoidance Beliefs Questionnaire (FABQ)

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

Experimental group

Description:

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

Treatment:

Other: Pain Catastrophizing

Other: Numerical Rating Score (NRS)

Diagnostic Test: Blood Test

Other: Saint Louis University Mental Status Examination (SLUMs)

Other: Opioid Side Effects and Likeability Questionnaire

Other: Oswestry Disability Index (ODI)

Other: Delirium Rating Scale-Revised-98 (DRS)

Other: Daily Pain Trajectory

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

Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Other: 3D CAM Delirium Severity Scoring

Other: Tampa Scale of Kinesiophobia

Other: Patient Health Questionnaire depression scale (PHQ-8)

Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)

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

Other: PROMIS-Pain Interference

Other: Quality of Recovery 15

Other: Fear Avoidance Beliefs Questionnaire (FABQ)