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

Обзор

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.

Вмешательства

• Препарат 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.
• Диагностический тест Blood Test
  Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
• Другое 3D CAM Delirium Severity Scoring
  Questionnaire that will rate each symptom of delirium
• Другое Generalized Anxiety Disorder 7-item (GAD-7) scale
  Questionnaire for screening and severity measurement of generalized anxiety disorder.
• Другое Numerical Rating Score (NRS)
  Questionnaire assessing pain intensity
• Другое PROMIS-Pain Interference
  Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
• Другое Oswestry Disability Index (ODI)
  Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
• Другое Saint Louis University Mental Status Examination (SLUMs)
  Questionnaire assessing baseline cognition.
• Другое Delirium Rating Scale-Revised-98 (DRS)
  16 item clinician rated scale assessing delirium severity.
• Другое Telephone Interview for Cognitive Status - Modified (TICS-M)
  Telephone interview questionnaire evaluating patient cognitive status.

Первичные конечные точки

• Numerical Rating Score [Срок оценки: Change assessed from pre-surgery to 12 weeks post-operatively.]
• Daily Pain Trajectory [Срок оценки: Change assessed from 1 day to 30 days post-operatively]
• Pain Catastrophizing [Срок оценки: Change from Pre-operation score to 12 weeks post-operatively]
• Pain Fear and Avoidance [Срок оценки: Change from Pre-operation score to 12 weeks post-operatively]
• Pain Interference [Срок оценки: Change from Pre-operation score to 12 weeks post-operatively]
• Generalized Anxiety Disorder [Срок оценки: Change from pre-operation score to 12 weeks post-operatively]
• Personal Health Questionnaire Depression Scale [Срок оценки: Change from pre-operation score to 12 weeks post-operatively]
• Oswestry disability index [Срок оценки: Change from Pre-operative score to 12 weeks post-operatively]
• Tampa Scale of Kinesiophobia [Срок оценки: Change from Pre-operative score to 12 weeks post-operatively]
• Delirium Rating Scale-Revised-98 [Срок оценки: Change from Pre-operative score to 12 weeks post-operatively]

Вторичные конечные точки (7)

• Opioid Use [Срок оценки: Change from pre-operative score through 12 weeks post-operatively]
• Opioid Side Effects and Likability Questionnaire [Срок оценки: Change from 1 week post-operative results to 4 weeks post-operation.]
• Self-reported Adverse Events [Срок оценки: Change from pre-operative result through 12 weeks post-operatively.]
• Length of Hospitalization [Срок оценки: Through study completion, 16 months]
• Disposition to skilled-facilities [Срок оценки: Through study completion, 16 months]
• 90-day Readmission Rates [Срок оценки: Through study completion, 16 months]
• Blood test for Inflammation [Срок оценки: Measured Immediately before surgery and 1 day post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Iowa — Iowa City

Публикации

• Brown CH 4th, LaFlam A, Max L, Wyrobek J, Neufeld KJ, Kebaish KM, Cohen DB, Walston JD, Hogue CW, Riley LH. Delirium After Spine Surgery in Older Adults: Incidence, Risk Factors, and Outcomes. J Am Geriatr Soc. 2016 Oct;64(10):2101-2108. doi: 10.1111/jgs.14434. Epub 2016 Oct 3. PMID 27696373
• Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019. PMID 9539601
• Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76. PMID 12560416
• Wenk M, Liljenqvist U, Kaulingfrecks T, Gurlit S, Ermert T, Popping DM, Mollmann M. Intra- versus postoperative initiation of pain control via a thoracic epidural catheter for lumbar spinal fusion surgery. Minerva Anestesiol. 2018 Jul;84(7):796-802. doi: 10.23736/S0375-9393.17.12136-X. Epub 2017 Oct 4. PMID 28984097
• Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019. PMID 31681518
• Ye Y, Bi Y, Ma J, Liu B. Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. PLoS One. 2021 May 21;16(5):e0251980. doi: 10.1371/journal.pone.0251980. eCollection 2021. PMID 34019598
• Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available. PMID 11172169
• Cassidy JD, Carroll LJ, Cote P. The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998 Sep 1;23(17):1860-6; discussion 1867. doi: 10.1097/00007632-199809010-00012. PMID 9762743

Идентификаторы

NCT: NCT05461092 · 202305284

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗