Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
NCT ID: NCT05461092
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
EARLY_PHASE1
50 participants
INTERVENTIONAL
2024-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
Quality of Recovery 15
Questionnaire assessing postoperative quality of recovery
Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
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.
Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
Quality of Recovery 15
Questionnaire assessing postoperative quality of recovery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Blood Test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
3D CAM Delirium Severity Scoring
Questionnaire that will rate each symptom of delirium
Generalized Anxiety Disorder 7-item (GAD-7) scale
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Numerical Rating Score (NRS)
Questionnaire assessing pain intensity
PROMIS-Pain Interference
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Oswestry Disability Index (ODI)
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Saint Louis University Mental Status Examination (SLUMs)
Questionnaire assessing baseline cognition.
Delirium Rating Scale-Revised-98 (DRS)
16 item clinician rated scale assessing delirium severity.
Telephone Interview for Cognitive Status - Modified (TICS-M)
Telephone interview questionnaire evaluating patient cognitive status.
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)
The amount of opioids administered will be collected through patient self-report
Patient Health Questionnaire depression scale (PHQ-8)
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Pain Catastrophizing
Scale used to determine pain catastrophizing and it's severity.
Fear Avoidance Beliefs Questionnaire (FABQ)
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Opioid Side Effects and Likeability Questionnaire
Survey determining adverse events related to opioid side effects and complications.
Daily Pain Trajectory
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Tampa Scale of Kinesiophobia
Questionnaire assessing Kinesiophobia
Quality of Recovery 15
Questionnaire assessing postoperative quality of recovery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Iowa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Catherine R. Olinger
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine R Olinger, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Khalifeh JM, Dibble CF, Hawasli AH, Ray WZ. Patient-Reported Outcomes Measurement Information System physical function and pain interference in spine surgery. J Neurosurg Spine. 2019 Apr 26;31(2):165-174. doi: 10.3171/2019.2.SPINE181237. Print 2019 Aug 1.
Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
Vila H Jr, Smith RA, Augustyniak MJ, Nagi PA, Soto RG, Ross TW, Cantor AB, Strickland JM, Miguel RV. The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: is patient safety compromised by treatment based solely on numerical pain ratings? Anesth Analg. 2005 Aug;101(2):474-480. doi: 10.1213/01.ANE.0000155970.45321.A8.
Rakel BA, Zimmerman BM, Geasland K, Embree J, Clark CR, Noiseux NO, Callaghan JJ, Herr K, Walsh D, Sluka KA. Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial. Pain. 2014 Dec;155(12):2599-2611. doi: 10.1016/j.pain.2014.09.025. Epub 2014 Sep 28.
Coronado RA, George SZ, Devin CJ, Wegener ST, Archer KR. Pain Sensitivity and Pain Catastrophizing Are Associated With Persistent Pain and Disability After Lumbar Spine Surgery. Arch Phys Med Rehabil. 2015 Oct;96(10):1763-70. doi: 10.1016/j.apmr.2015.06.003. Epub 2015 Jun 20.
Dunn LK, Durieux ME, Fernandez LG, Tsang S, Smith-Straesser EE, Jhaveri HF, Spanos SP, Thames MR, Spencer CD, Lloyd A, Stuart R, Ye F, Bray JP, Nemergut EC, Naik BI. Influence of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain, and quality of recovery after adult spine surgery. J Neurosurg Spine. 2018 Jan;28(1):119-126. doi: 10.3171/2017.5.SPINE1734. Epub 2017 Nov 10.
Nwankwo VC, Jiranek WA, Green CL, Allen KD, George SZ, Bettger JP. Resilience and pain catastrophizing among patients with total knee arthroplasty: a cohort study to examine psychological constructs as predictors of post-operative outcomes. Health Qual Life Outcomes. 2021 May 1;19(1):136. doi: 10.1186/s12955-021-01772-2.
Sanders RD, Pandharipande PP, Davidson AJ, Ma D, Maze M. Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011 Jul 20;343:d4331. doi: 10.1136/bmj.d4331. No abstract available.
Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.
Fong HK, Sands LP, Leung JM. The role of postoperative analgesia in delirium and cognitive decline in elderly patients: a systematic review. Anesth Analg. 2006 Apr;102(4):1255-66. doi: 10.1213/01.ane.0000198602.29716.53.
Leung JM, Sands LP, Lim E, Tsai TL, Kinjo S. Does preoperative risk for delirium moderate the effects of postoperative pain and opiate use on postoperative delirium? Am J Geriatr Psychiatry. 2013 Oct;21(10):946-56. doi: 10.1016/j.jagp.2013.01.069. Epub 2013 May 6.
Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af.
Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.
Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
Garg B, Ahuja K, Khanna P, Sharan AD. Regional Anesthesia for Spine Surgery. Clin Spine Surg. 2021 Jun 1;34(5):163-170. doi: 10.1097/BSD.0000000000001096. Epub 2020 Oct 9.
Bicak M, Aktas U, Salik F, Akelma H, Bicak EA, Kaya S. Comparison of Thoracolumbar Interfascial Plane Block with the Application of Local Anesthesia in the Management of Postoperative Pain in Patients with Lumbar Disc Surgery. Turk Neurosurg. 2021;31(5):757-762. doi: 10.5137/1019-5149.JTN.33017-20.2.
Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
Ohgoshi Y, Namiki R, Kori S, Matsukawa M. The use of ultrasound-guided thoracolumbar interfascial plane block for multi-level lumbar spinal surgery. J Clin Anesth. 2017 Feb;37:162. doi: 10.1016/j.jclinane.2016.12.025. Epub 2017 Jan 10. No abstract available.
Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.
Ueshima H. Retraction notice to "Lumbar thoracolumbar interfascial plane block provides effective analgesia for spondylosis" [J. Clin. Anesth. 57 (2019)37]. J Clin Anesth. 2022 Aug;79:110762. doi: 10.1016/j.jclinane.2022.110762. Epub 2022 Apr 4. No abstract available.
Morgenstern C, Ramirez-Paesano C, Juanola Galceran A, Morgenstern R. Thoracolumbar Interfascial Plane Block Results in Opioid-Free Postoperative Recovery After Percutaneous/Endoscopic Transforaminal Lumbar Interbody Fusion Surgery. World Neurosurg. 2021 Sep;153:e473-e480. doi: 10.1016/j.wneu.2021.06.152. Epub 2021 Jul 6.
Gao H, Ma HJ, Li YJ, Yin C, Li Z. Prevalence and risk factors of postoperative delirium after spinal surgery: a meta-analysis. J Orthop Surg Res. 2020 Apr 9;15(1):138. doi: 10.1186/s13018-020-01651-4.
Farag E, Seif J. Thoracolumbar interfascial block (TLIP): A new technique of interfascial plane blocks. J Clin Anesth. 2020 May;61:109640. doi: 10.1016/j.jclinane.2019.109640. Epub 2019 Oct 28. No abstract available.
Shin C, Lee SH, Han KM, Yoon HK, Han C. Comparison of the Usefulness of the PHQ-8 and PHQ-9 for Screening for Major Depressive Disorder: Analysis of Psychiatric Outpatient Data. Psychiatry Investig. 2019 Apr;16(4):300-305. doi: 10.30773/pi.2019.02.01. Epub 2019 Apr 24.
Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b.
Ahn SH, Choi JH, Im CS, Kim TS, Kim JL. A Comparison of the Severe Cognitive Impairment Rating Scale With the Mini-Mental State Examination and Delirium Rating Scale-Revised-98 for Delirium: A Cross-sectional Study. Psychosomatics. 2017 Nov-Dec;58(6):643-651. doi: 10.1016/j.psym.2017.08.002. Epub 2017 Aug 5.
Marcantonio ER, Ngo LH, O'Connor M, Jones RN, Crane PK, Metzger ED, Inouye SK. 3D-CAM: derivation and validation of a 3-minute diagnostic interview for CAM-defined delirium: a cross-sectional diagnostic test study. Ann Intern Med. 2014 Oct 21;161(8):554-61. doi: 10.7326/M14-0865.
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
Olbert M, Eckert S, Morgeli R, Kruppa J, Spies CD. Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study. Eur J Anaesthesiol. 2019 Sep;36(9):683-687. doi: 10.1097/EJA.0000000000001048.
Tariq SH, Tumosa N, Chibnall JT, Perry MH 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the mini-mental state examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006 Nov;14(11):900-10. doi: 10.1097/01.JGP.0000221510.33817.86.
Yadeau JT, Liu SS, Rade MC, Marcello D, Liguori GA. Performance characteristics and validation of the Opioid-Related Symptom Distress Scale for evaluation of analgesic side effects after orthopedic surgery. Anesth Analg. 2011 Aug;113(2):369-77. doi: 10.1213/ANE.0b013e31821ae3f7. Epub 2011 Apr 27.
Jamison RN, Dorado K, Mei A, Edwards RR, Martel MO. Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care. Pain Rep. 2017 Mar 6;2(2):e589. doi: 10.1097/PR9.0000000000000589. eCollection 2017 Mar.
Glare P, Walsh D, Sheehan D. The adverse effects of morphine: a prospective survey of common symptoms during repeated dosing for chronic cancer pain. Am J Hosp Palliat Care. 2006 Jun-Jul;23(3):229-35. doi: 10.1177/1049909106289068.
Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824-836. doi: 10.1002/art.41170. Epub 2020 Mar 18.
Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015 Sep 14;16:253. doi: 10.1186/s12891-015-0715-y.
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
Asher AL, Kerezoudis P, Mummaneni PV, Bisson EF, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Coric D, Knightly JJ, Park P, Fu KM, Devin CJ, Archer KR, Chotai S, Chan AK, Virk MS, Bydon M. Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database. Neurosurg Focus. 2018 Jan;44(1):E2. doi: 10.3171/2017.10.FOCUS17554.
Goudman L, Smedt A, Forget P, Moens M. Determining the Minimal Clinical Important Difference for Medication Quantification Scale III and Morphine Milligram Equivalents in Patients with Failed Back Surgery Syndrome. J Clin Med. 2020 Nov 21;9(11):3747. doi: 10.3390/jcm9113747.
Brock JL, Jain N, Phillips FM, Malik AT, Khan SN. Postoperative opioid cessation rates based on preoperative opioid use: analysis of common orthopaedic procedures. Bone Joint J. 2019 Dec;101-B(12):1570-1577. doi: 10.1302/0301-620X.101B12.BJJ-2019-0080.R2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202305284
Identifier Type: -
Identifier Source: org_study_id