Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
A legfontosabb adatok
- Ki végzi
- University of Iowa
- Hol
- Iowa City (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- Korai 1. fázis
- Résztvevők
- 50 fő, tervezett
- Kezdés
- 2024. jan. 1.
- Várható befejezés
- 2026. dec. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
- Blood Test
- 3D CAM Delirium Severity Scoring
- Generalized Anxiety Disorder 7-item (GAD-7) scale
- Numerical Rating Score (NRS)
- PROMIS-Pain Interference
- Oswestry Disability Index (ODI)
- Saint Louis University Mental Status Examination (SLUMs)
- Delirium Rating Scale-Revised-98 (DRS)
- Telephone Interview for Cognitive Status - Modified (TICS-M)
- Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
- Patient Health Questionnaire depression scale (PHQ-8)
- Pain Catastrophizing
- Fear Avoidance Beliefs Questionnaire (FABQ)
- Opioid Side Effects and Likeability Questionnaire
- Daily Pain Trajectory
- Tampa Scale of Kinesiophobia
- Quality of Recovery 15
- A regiszteradat frissítve
- 2026. március 27.
Ki vehet részt
- Életkor
- 65 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 22 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- seeking revision surgery
- patients with previous diagnosis of dementia or SLUMS score <20
- coexisting hematological disorder or irreversible abnormal coagulation
- allergy to study medications
- patients with associated significant CNS or respiratory disease (home oxygen requirements)
- psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
- 64 years old and younger
- emergency treatment
- pathologic fractures
- major liver or kidney dysfunction
- patient unable to communicate/cooperate/language barrier
- BMI>40
- opioid tolerant (oral opioid intake morphine equivalent =< 60 mg/day)
- other sources of chronic pain like fibromyalgia
- incarcerated patients
- pregnant or breast feeding
Helyszínek itt: Egyesült Államok
- University of IowaIowa City, Egyesült ÁllamokContact: Alex R Coffman, BSRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Már használt kezelés, összehasonlításként
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Kezelés: Blood Test, 3D CAM Delirium Severity Scoring, Generalized Anxiety Disorder 7-item (GAD-7) scale, Numerical Rating Score (NRS), PROMIS-Pain Interference, Oswestry Disability Index (ODI), Saint Louis University Mental Status Examination (SLUMs), Delirium Rating Scale-Revised-98 (DRS), Telephone Interview for Cognitive Status - Modified (TICS-M), Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Patient Health Questionnaire depression scale (PHQ-8), Pain Catastrophizing, Fear Avoidance Beliefs Questionnaire (FABQ), Opioid Side Effects and Likeability Questionnaire, Daily Pain Trajectory, Tampa Scale of Kinesiophobia és Quality of Recovery 15
- Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineA vizsgált kezelés
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Kezelés: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Blood Test, 3D CAM Delirium Severity Scoring, Generalized Anxiety Disorder 7-item (GAD-7) scale, Numerical Rating Score (NRS), PROMIS-Pain Interference, Oswestry Disability Index (ODI), Saint Louis University Mental Status Examination (SLUMs), Delirium Rating Scale-Revised-98 (DRS), Telephone Interview for Cognitive Status - Modified (TICS-M), Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Patient Health Questionnaire depression scale (PHQ-8), Pain Catastrophizing, Fear Avoidance Beliefs Questionnaire (FABQ), Opioid Side Effects and Likeability Questionnaire, Daily Pain Trajectory, Tampa Scale of Kinesiophobia és Quality of Recovery 15
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. március 27.