DeliriumEarly Phase 1NCT05461092
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
A Early Phase 1 study testing Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Blood Test and 3D CAM Delirium Severity Scoring in people with Delirium and Pain, Back, run by University of Iowa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Pain, Back, Spinal Fusion
- What is being tested?
- Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Blood Test and 3D CAM Delirium Severity Scoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 64 years old and younger
- emergency treatment
- pathologic fractures
- seeking revision surgery
- major liver or kidney dysfunction
- coexisting hematological disorder or irreversible abnormal coagulation
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
About this study
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.
- Being tested
- 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)
- Medical subject headings
- Delirium, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineDrug
Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Blood TestDiagnostic test
Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa
3D CAM Delirium Severity ScoringOther
Questionnaire that will rate each symptom of delirium
Generalized Anxiety Disorder 7-item (GAD-7) scaleOther
Questionnaire for screening and severity measurement of generalized anxiety disorder.
Numerical Rating Score (NRS)Other
Questionnaire assessing pain intensity
PROMIS-Pain InterferenceOther
Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.
Oswestry Disability Index (ODI)Other
Questionnaire assessing disability and quality of life impairment in adults with lower back pain.
Saint Louis University Mental Status Examination (SLUMs)Other
Questionnaire assessing baseline cognition.
Delirium Rating Scale-Revised-98 (DRS)Other
16 item clinician rated scale assessing delirium severity.
Telephone Interview for Cognitive Status - Modified (TICS-M)Other
Telephone interview questionnaire evaluating patient cognitive status.
Opioid Equivalents measured by Morphine Milligram Equivalents (MME)Other
The amount of opioids administered will be collected through patient self-report
Patient Health Questionnaire depression scale (PHQ-8)Other
Questionnaire used to diagnose and determine the severity measure for depressive disorders.
Pain CatastrophizingOther
Scale used to determine pain catastrophizing and it's severity.
Fear Avoidance Beliefs Questionnaire (FABQ)Other
Questionnaire used to help predict patients that have a high pain avoidance behavior.
Opioid Side Effects and Likeability QuestionnaireOther
Survey determining adverse events related to opioid side effects and complications.
Daily Pain TrajectoryOther
Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.
Tampa Scale of KinesiophobiaOther
Questionnaire assessing Kinesiophobia
Quality of Recovery 15Other
Questionnaire assessing postoperative quality of recovery
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine. | Active comparator | Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine. Receives: Diagnostic Test: Blood Test; Other: 3D CAM Delirium Severity Scoring; Other: Generalized Anxiety Disorder 7-item (GAD-7) scale; Other: Numerical Rating Score (NRS); Other: PROMIS-Pain Interference; Other: Oswestry Disability Index (ODI); Other: Saint Louis University Mental Status Examination (SLUMs); Other: Delirium Rating Scale-Revised-98 (DRS); Other: Telephone Interview for Cognitive Status - Modified (TICS-M); Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME); Other: Patient Health Questionnaire depression scale (PHQ-8); Other: Pain Catastrophizing; Other: Fear Avoidance Beliefs Questionnaire (FABQ); Other: Opioid Side Effects and Likeability Questionnaire; Other: Daily Pain Trajectory; Other: Tampa Scale of Kinesiophobia; Other: Quality of Recovery 15 |
| Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine | Experimental | Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion. Receives: Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Diagnostic Test: Blood Test; Other: 3D CAM Delirium Severity Scoring; Other: Generalized Anxiety Disorder 7-item (GAD-7) scale; Other: Numerical Rating Score (NRS); Other: PROMIS-Pain Interference; Other: Oswestry Disability Index (ODI); Other: Saint Louis University Mental Status Examination (SLUMs); Other: Delirium Rating Scale-Revised-98 (DRS); Other: Telephone Interview for Cognitive Status - Modified (TICS-M); Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME); Other: Patient Health Questionnaire depression scale (PHQ-8); Other: Pain Catastrophizing; Other: Fear Avoidance Beliefs Questionnaire (FABQ); Other: Opioid Side Effects and Likeability Questionnaire; Other: Daily Pain Trajectory; Other: Tampa Scale of Kinesiophobia; Other: Quality of Recovery 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Score
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Measured: Change assessed from pre-surgery to 12 weeks post-operatively.
Daily Pain Trajectory
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
Measured: Change assessed from 1 day to 30 days post-operatively
Pain Catastrophizing
Change in pain catastrophizing and severity will be assessed using the Pain Catastrophizing scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operation score to 12 weeks post-operatively
Pain Fear and Avoidance
Change in pain fear and subject avoidance will be assessed using the Pain Fear and Avoidance Questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operation score to 12 weeks post-operatively
Pain Interference
Change in how pain interferes with patient physical, emotional, and social functioning will be assessed using the PROMIS - Pain Interference questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operation score to 12 weeks post-operatively
Generalized Anxiety Disorder
Change in severity measurement of generalized anxiety disorder assessed using the Generalized Anxiety Disorder 7 item scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from pre-operation score to 12 weeks post-operatively
Personal Health Questionnaire Depression Scale
Change in depression will be assessed using the Personal Health Questionnaire Depression Scale measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from pre-operation score to 12 weeks post-operatively
Oswestry disability index
Change in disability score will be assessed using the Oswestry disability index measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively
Tampa Scale of Kinesiophobia
Change in kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively
Delirium Rating Scale-Revised-98
Change in delirium severity will be assessed using the Delirium Rating Scale-Revised-98 16 item clinician rated scale measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively
3D-CAM-S and 3D-CAM-ICU
Change in delirium symptoms will be assessed using the 3D-CAM-S and 3D-CAM-ICU Questionnaire measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively
Modified Telephone Interview of Cognitive Status
Change in cognitive status will be assessed using the Modified Telephone Interview of cognitive Status measured immediately before surgery and at 6, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively
Saint Louis University Mental Status Examination (SLUMs)
Change in baseline cognition will be assessed using the Saint Louis University Mental Status Examination measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Measured: Change from Pre-operative score to 12 weeks post-operatively.
Secondary outcomes (7)
Opioid Use
Opioid use will be calculated pre- and post-operatively using the Morphine Milligram Equivalents from patient self-reports.
Measured: Change from pre-operative score through 12 weeks post-operatively
Opioid Side Effects and Likability Questionnaire
Change in adverse events related to opioid side effects and complications will be assessed using the Opioid Side Effects and Likeability Questionnaire measured 1 week and 4 weeks post-operatively.
Measured: Change from 1 week post-operative results to 4 weeks post-operation.
Self-reported Adverse Events
Change in adverse events related to opioid use and post-surgical outcomes will be collected post-operatively through the electronic health record from patient self-report. This will be measured immediately before surgery and 1, 2, 4, 6, and 12 weeks post-operatively
Measured: Change from pre-operative result through 12 weeks post-operatively.
Length of Hospitalization
The length of time patients were hospitalized will be collected through the electronic health record.
Measured: Through study completion, 16 months
Disposition to skilled-facilities
Where patients are dispositioned post-operatively will be collected through the electronic health record.
Measured: Through study completion, 16 months
90-day Readmission Rates
The 90-day readmission rates will be collected through the electronic health record.
Measured: Through study completion, 16 months
Blood test for Inflammation
Blood test for IL-10, MCP-1, NfL, IL-6, and IL-8 will be done pre- and post-surgery for presence and levels of IL-10, MCP-1, NfL, IL-6, and IL-8.
Measured: Measured Immediately before surgery and 1 day post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine R. Olinger, University of Iowa
- Investigators
- Catherine R Olinger, MD, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461092
- Sponsor's protocol ID
- 202305284
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27696373Lynch 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.
PubMed 9539601Morrison 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.
PubMed 12560416Wenk 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.
PubMed 28984097Chen 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.
PubMed 31681518Ye 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.
PubMed 34019598Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169Cassidy 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.
PubMed 9762743Khalifeh 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.
PubMed 31026819Khanna 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.
PubMed 32925318Vila 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.
PubMed 16037164Rakel 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.
PubMed 25270585Coronado 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.
PubMed 26101845Dunn 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.
PubMed 29125426Nwankwo 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.
PubMed 33933091
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
- ClinicalTrials.gov ID
- NCT05461092
- Acronym / sponsor ID
- 202305284
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine. | Active comparator | Diagnostic Test: Blood Test, Other: 3D CAM Delirium Severity Scoring, Other: Generalized Anxiety Disorder 7-item (GAD-7) scale, Other: Numerical Rating Score (NRS), Other: PROMIS-Pain Interference, Other: Oswestry Disability Index (ODI), Other: Saint Louis University Mental Status Examination (SLUMs), Other: Delirium Rating Scale-Revised-98 (DRS), Other: Telephone Interview for Cognitive Status - Modified (TICS-M), Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Other: Patient Health Questionnaire depression scale (PHQ-8), Other: Pain Catastrophizing, Other: Fear Avoidance Beliefs Questionnaire (FABQ), Other: Opioid Side Effects and Likeability Questionnaire, Other: Daily Pain Trajectory, Other: Tampa Scale of Kinesiophobia, Other: Quality of Recovery 15Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine. |
| Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine | Experimental | Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Diagnostic Test: Blood Test, Other: 3D CAM Delirium Severity Scoring, Other: Generalized Anxiety Disorder 7-item (GAD-7) scale, Other: Numerical Rating Score (NRS), Other: PROMIS-Pain Interference, Other: Oswestry Disability Index (ODI), Other: Saint Louis University Mental Status Examination (SLUMs), Other: Delirium Rating Scale-Revised-98 (DRS), Other: Telephone Interview for Cognitive Status - Modified (TICS-M), Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME), Other: Patient Health Questionnaire depression scale (PHQ-8), Other: Pain Catastrophizing, Other: Fear Avoidance Beliefs Questionnaire (FABQ), Other: Opioid Side Effects and Likeability Questionnaire, Other: Daily Pain Trajectory, Other: Tampa Scale of Kinesiophobia, Other: Quality of Recovery 15Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 64 years old and younger
- emergency treatment
- pathologic fractures
- seeking revision surgery
- major liver or kidney dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbar Interfascial Plane (TLIP) Block of bupivacainePatient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion. | Drug | Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine |
| Blood TestBlood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa | Diagnostic test | 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 ScoringQuestionnaire that will rate each symptom of delirium | Other | 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) scaleQuestionnaire for screening and severity measurement of generalized anxiety disorder. | Other | 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 | Other | 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 InterferenceQuestionnaire measuring the effect of pain on patient physical, emotional, and social functioning. | Other | 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. | Other | 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. | Other | 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. | Other | 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. | Other | 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 | Other | 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. | Other | 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 CatastrophizingScale used to determine pain catastrophizing and it's severity. | Other | 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. | Other | 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 QuestionnaireSurvey determining adverse events related to opioid side effects and complications. | Other | 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 TrajectoryQuestionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate. | Other | 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 KinesiophobiaQuestionnaire assessing Kinesiophobia | Other | 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 15Questionnaire assessing postoperative quality of recovery | Other | Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine. |
Primary outcome
Numerical Rating Score
Time frame: Change assessed from pre-surgery to 12 weeks post-operatively.
Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.
Daily Pain Trajectory
Time frame: Change assessed from 1 day to 30 days post-operatively
Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.
Pain Catastrophizing
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Change in pain catastrophizing and severity will be assessed using the Pain Catastrophizing scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Pain Fear and Avoidance
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Change in pain fear and subject avoidance will be assessed using the Pain Fear and Avoidance Questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Pain Interference
Time frame: Change from Pre-operation score to 12 weeks post-operatively
Change in how pain interferes with patient physical, emotional, and social functioning will be assessed using the PROMIS - Pain Interference questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Generalized Anxiety Disorder
Time frame: Change from pre-operation score to 12 weeks post-operatively
Change in severity measurement of generalized anxiety disorder assessed using the Generalized Anxiety Disorder 7 item scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Personal Health Questionnaire Depression Scale
Time frame: Change from pre-operation score to 12 weeks post-operatively
Change in depression will be assessed using the Personal Health Questionnaire Depression Scale measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Oswestry disability index
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Change in disability score will be assessed using the Oswestry disability index measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Tampa Scale of Kinesiophobia
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Change in kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
Delirium Rating Scale-Revised-98
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Change in delirium severity will be assessed using the Delirium Rating Scale-Revised-98 16 item clinician rated scale measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
3D-CAM-S and 3D-CAM-ICU
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Change in delirium symptoms will be assessed using the 3D-CAM-S and 3D-CAM-ICU Questionnaire measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.
Modified Telephone Interview of Cognitive Status
Time frame: Change from Pre-operative score to 12 weeks post-operatively
Change in cognitive status will be assessed using the Modified Telephone Interview of cognitive Status measured immediately before surgery and at 6, and 12 weeks post-operatively.
Saint Louis University Mental Status Examination (SLUMs)
Time frame: Change from Pre-operative score to 12 weeks post-operatively.
Change in baseline cognition will be assessed using the Saint Louis University Mental Status Examination measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.
7 secondary outcomes
Opioid Use
Time frame: Change from pre-operative score through 12 weeks post-operatively
Opioid Side Effects and Likability Questionnaire
Time frame: Change from 1 week post-operative results to 4 weeks post-operation.
Self-reported Adverse Events
Time frame: Change from pre-operative result through 12 weeks post-operatively.
Length of Hospitalization
Time frame: Through study completion, 16 months
Disposition to skilled-facilities
Time frame: Through study completion, 16 months
90-day Readmission Rates
Time frame: Through study completion, 16 months
Blood test for Inflammation
Time frame: Measured Immediately before surgery and 1 day post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 27696373Brown 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.
- Background: PubMed 9539601Lynch 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.
- Background: PubMed 12560416Morrison 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.
- Background: PubMed 28984097Wenk 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.
- Background: PubMed 31681518Chen 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.
- Background: PubMed 34019598Ye 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.
- Background: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
- Background: PubMed 9762743Cassidy 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.
- Background: PubMed 31026819Khalifeh 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.
- Background: PubMed 32925318Khanna 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.
- Background: PubMed 16037164Vila 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.
- Background: PubMed 25270585Rakel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine R Olinger, MD principal investigator
Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine, Blood Test and 3D CAM Delirium Severity Scoring in people with Delirium and Pain, Back, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex R Coffman, BS (319-353-8996, alex-coffman@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Score (time frame: Change assessed from pre-surgery to 12 weeks post-operatively.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461092, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.