Postoperative DeliriumPhase 2NCT06199999
Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery
A Phase 2 study testing Erector Spinae Block and Local infiltration with local anesthetic in people with Postoperative Delirium and Pain, Postoperative, run by Rashmi Mueller at 1 site in United States.
Trial summary
The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Delirium, Pain, Postoperative, Degenerative Disc Disease
- What is being tested?
- Erector Spinae Block and Local infiltration with local anesthetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 29 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Greater than 18 years but less than 80
- Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
- Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
- No contraindication to local anesthetics or regional procedures.
Who cannot join
- Emergency surgery
- Allergy to study medications
- BMI less than 20 or greater than 50
- Major liver or kidney dysfunction or other pre-existing major organ dysfunction
- Revision surgery
- Opioid tolerant (60 mg morphine equivalents/day for 1 week) or narcotic dependence (opioid intake morphine equivalent greater than10 mg/day for more than 3 months)
Show all 17Show fewer
- Other sources of chronic pain (e.g. fibromyalgia)
- Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use)
- Pre-operative neurological deficits
- Co-existing hematological disorders or deranged coagulation parameters
- Significant psychiatric illnesses that impedes the subject's ability to provide informed consent
- Language barrier
- Vulnerable population (e.g. prisoners)
- Pregnant females
- History of recent myocardial infarction
- History of recent cardiac stent procedure (within 3 months)
- Cardiac ejection fraction < 30%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Health Care Medical Center
Iowa City, Iowa, 52242
About this study
Official title: A Randomized Controlled Trial Comparing the Effect of Erector Spinae Plane Blocks Versus High Volume Local Infiltration Analgesia on Pain, Inflammation and Cognitive Outcomes Following Thoraco-Lumbar Fusion Surgery
The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.
Read the detailed description
Treatment arms include:
- Group ESP (Erector Spinae Plane). This group receives general anesthesia with ESP (Erector Spinae Block) regional pain block prior to incision.
- Group LIA (Local Infiltration Anesthesia). This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated using local anesthetic (LIA).
- Group GA. This group receives general anesthesia (GA) only and surgical procedure will follow standard conditions.
Pre-procedure activities for all groups will include survey evaluations. If the surveys demonstrate pre-procedure cognitive deficits, the subject's participation will cease.
All subjects who do not display deficits will complete baseline evaluations that include social history, pain medication history and rate their pain (scored from 1 to 10). The subjects will be randomized to a treatment group. Once the subject is asleep and prior to incision, laboratory blood tests will be drawn and again approximately 24 hours after the subject is received into the recovery unit. Following their surgical procedure, pain control for all subjects will be at the discretion of their primary care team. However, as part of the study, the amount of opioid medications required to control their pain and their pain rating score for the first 72 hours post surgery will be collected from the subject's medical record unless discharged from the hospital before this cutoff time. On post-operative days when subject remains in the hospital facility, repeat survey evaluations will be carried out and during the first 7 days of the subject's hospital stay and unanticipated event will be recorded from the subject's medical record.
- Being tested
- Erector Spinae Block, Local infiltration with local anesthetic
- Medical subject headings
- Emergence Delirium, Pain, Postoperative, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae BlockProcedure or surgery
General anesthesia with Erector Spinae Plane Block
Local infiltration with local anestheticProcedure or surgery
General anesthesia with local infiltration of local anesthetic:
| Study group | Role | What they receive |
|---|---|---|
| Group GA: General anesthesia only | No intervention | This group receives general anesthesia only and surgical procedure will follow standard conditions. |
| Group ESP: Erector Spinae Block | Active comparator | This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision. Receives: Procedure: Erector Spinae Block |
| Group LIA: Local Infiltration | Active comparator | This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated. Receives: Procedure: Local infiltration with local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups
The Quality of Recovery-15 (QoR-15) is a patient reported assessment aimed to validate the patients recovery following surgical intervention. The subject is asked to provide a quantitative number to a series of questions. The answers are rated on a scale from 0 to 10, where 0 = none of the time and 10 = all of the time. The scores for all of the questions are summed and comparison between the treatment groups will be assessed.
Measured: Change from pre-operation score to 1 day after surgery date
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1
Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness."
Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported.
Reference: Marcantonio et al., (PMID: 25329203) and training manual.
Measured: Change from pre-operation score to 1 day after surgery date
Secondary outcomes (1)
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 3
Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness."
Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported.
Reference: Marcantonio et al., (PMID: 25329203) and training manual.
Measured: Change from pre-operation score to 3 days after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 May 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rashmi Mueller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rashmi Mueller, University of Iowa
- Investigators
- Rashmi Mueller, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199999
- Sponsor's protocol ID
- 202201643
- Status last verified
- May 2025
- First submitted
- 28 Dec 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
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 27696373Dunne SS, Coffey JC, Konje S, Gasior S, Clancy CC, Gulati G, Meagher D, Dunne CP. Biomarkers in delirium: A systematic review. J Psychosom Res. 2021 Aug;147:110530. doi: 10.1016/j.jpsychores.2021.110530. Epub 2021 Jun 1.
PubMed 34098376Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.
PubMed 14710509Etzioni DA, Liu JH, O'Connell JB, Maggard MA, Ko CY. Elderly patients in surgical workloads: a population-based analysis. Am Surg. 2003 Nov;69(11):961-5.
PubMed 14627256Fineberg SJ, Nandyala SV, Marquez-Lara A, Oglesby M, Patel AA, Singh K. Incidence and risk factors for postoperative delirium after lumbar spine surgery. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1790-6. doi: 10.1097/BRS.0b013e3182a0d507.
PubMed 23797502Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Huang X, Wang J, Zhang J, Kang Y, Sandeep B, Yang J. Ultrasound-guided erector spinae plane block improves analgesia after laparoscopic hepatectomy: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):445-453. doi: 10.1016/j.bja.2022.05.013. Epub 2022 Jul 6.
PubMed 35803754Hughey AB, Lesniak MS, Ansari SA, Roth S. What will anesthesiologists be anesthetizing? Trends in neurosurgical procedure usage. Anesth Analg. 2010 Jun 1;110(6):1686-97. doi: 10.1213/ANE.0b013e3181cbd9cc. Epub 2010 Feb 8.
PubMed 20142356Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.
PubMed 32357842Kumar CD, Dietz N, Sharma M, Cruz A, Counts CE, Wang D, Ugiliweneza B, Boakye M, Drazin D. Spine Surgery in the Octogenarian Population: A Comparison of Demographics, Surgical Approach, and Healthcare Utilization With the PearlDiver Database. Cureus. 2021 Apr 19;13(4):e14561. doi: 10.7759/cureus.14561.
PubMed 34026377Lang SAJ, Bohn T, Barleben L, Pumberger M, Roll S, Buttner-Janz K. Advanced meta-analyses comparing the three surgical techniques total disc replacement, anterior stand-alone fusion and circumferential fusion regarding pain, function and complications up to 3 years to treat lumbar degenerative disc disease. Eur Spine J. 2021 Dec;30(12):3688-3701. doi: 10.1007/s00586-021-06784-6. Epub 2021 Apr 10.
PubMed 33837832Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.
PubMed 14576554Li K, Ji C, Luo D, Feng H, Yang K, Xu H. Wound infiltration with ropivacaine as an adjuvant to patient controlled analgesia for transforaminal lumbar interbody fusion: a retrospective study. BMC Anesthesiol. 2020 Nov 18;20(1):288. doi: 10.1186/s12871-020-01205-5.
PubMed 33208089Ma J, Bi Y, Zhang Y, Zhu Y, Wu Y, Ye Y, Wang J, Zhang T, Liu B. Erector spinae plane block for postoperative analgesia in spine surgery: a systematic review and meta-analysis. Eur Spine J. 2021 Nov;30(11):3137-3149. doi: 10.1007/s00586-021-06853-w. Epub 2021 May 13.
PubMed 33983515
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effect of Erector Spinae Plane Blocks Versus High Volume Local Infiltration Analgesia on Pain, Inflammation and Cognitive Outcomes Following Thoraco-Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT06199999
- Acronym / sponsor ID
- 202201643
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rashmi MuellerUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 10 Jan 2024 (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.
The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.
Detailed description
Treatment arms include:
- Group ESP (Erector Spinae Plane). This group receives general anesthesia with ESP (Erector Spinae Block) regional pain block prior to incision.
- Group LIA (Local Infiltration Anesthesia). This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated using local anesthetic (LIA).
- Group GA. This group receives general anesthesia (GA) only and surgical procedure will follow standard conditions.
Pre-procedure activities for all groups will include survey evaluations. If the surveys demonstrate pre-procedure cognitive deficits, the subject's participation will cease.
All subjects who do not display deficits will complete baseline evaluations that include social history, pain medication history and rate their pain (scored from 1 to 10). The subjects will be randomized to a treatment group. Once the subject is asleep and prior to incision, laboratory blood tests will be drawn and again approximately 24 hours after the subject is received into the recovery unit. Following their surgical procedure, pain control for all subjects will be at the discretion of their primary care team. However, as part of the study, the amount of opioid medications required to control their pain and their pain rating score for the first 72 hours post surgery will be collected from the subject's medical record unless discharged from the hospital before this cutoff time. On post-operative days when subject remains in the hospital facility, repeat survey evaluations will be carried out and during the first 7 days of the subject's hospital stay and unanticipated event will be recorded from the subject's medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group GA: General anesthesia only | No intervention | –This group receives general anesthesia only and surgical procedure will follow standard conditions. |
| Group ESP: Erector Spinae Block | Active comparator | Procedure: Erector Spinae BlockThis group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision. |
| Group LIA: Local Infiltration | Active comparator | Procedure: Local infiltration with local anestheticThis group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Greater than 18 years but less than 80
- Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
- Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
- No contraindication to local anesthetics or regional procedures.
Key exclusion criteria (17 listed)
- Emergency surgery
- Allergy to study medications
- BMI less than 20 or greater than 50
- Major liver or kidney dysfunction or other pre-existing major organ dysfunction
- Revision surgery
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 |
|---|---|---|
| Erector Spinae BlockGeneral anesthesia with Erector Spinae Plane Block | Procedure or surgery | Group ESP: Erector Spinae Block |
| Local infiltration with local anestheticGeneral anesthesia with local infiltration of local anesthetic: | Procedure or surgery | Group LIA: Local Infiltration |
Primary outcome
Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups
Time frame: Change from pre-operation score to 1 day after surgery date
The Quality of Recovery-15 (QoR-15) is a patient reported assessment aimed to validate the patients recovery following surgical intervention. The subject is asked to provide a quantitative number to a series of questions. The answers are rated on a scale from 0 to 10, where 0 = none of the time and 10 = all of the time. The scores for all of the questions are summed and comparison between the treatment groups will be assessed.
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1
Time frame: Change from pre-operation score to 1 day after surgery date
Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness." Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported. Reference: Marcantonio et al., (PMID: 25329203) and training manual.
1 secondary outcome
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 3
Time frame: Change from pre-operation score to 3 days after surgery date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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 34098376Dunne SS, Coffey JC, Konje S, Gasior S, Clancy CC, Gulati G, Meagher D, Dunne CP. Biomarkers in delirium: A systematic review. J Psychosom Res. 2021 Aug;147:110530. doi: 10.1016/j.jpsychores.2021.110530. Epub 2021 Jun 1.
- Background: PubMed 14710509Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.
- Background: PubMed 14627256Etzioni DA, Liu JH, O'Connell JB, Maggard MA, Ko CY. Elderly patients in surgical workloads: a population-based analysis. Am Surg. 2003 Nov;69(11):961-5.
- Background: PubMed 23797502Fineberg SJ, Nandyala SV, Marquez-Lara A, Oglesby M, Patel AA, Singh K. Incidence and risk factors for postoperative delirium after lumbar spine surgery. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1790-6. doi: 10.1097/BRS.0b013e3182a0d507.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 35803754Huang X, Wang J, Zhang J, Kang Y, Sandeep B, Yang J. Ultrasound-guided erector spinae plane block improves analgesia after laparoscopic hepatectomy: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):445-453. doi: 10.1016/j.bja.2022.05.013. Epub 2022 Jul 6.
- Background: PubMed 20142356Hughey AB, Lesniak MS, Ansari SA, Roth S. What will anesthesiologists be anesthetizing? Trends in neurosurgical procedure usage. Anesth Analg. 2010 Jun 1;110(6):1686-97. doi: 10.1213/ANE.0b013e3181cbd9cc. Epub 2010 Feb 8.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 32357842Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.
- Background: PubMed 34026377Kumar CD, Dietz N, Sharma M, Cruz A, Counts CE, Wang D, Ugiliweneza B, Boakye M, Drazin D. Spine Surgery in the Octogenarian Population: A Comparison of Demographics, Surgical Approach, and Healthcare Utilization With the PearlDiver Database. Cureus. 2021 Apr 19;13(4):e14561. doi: 10.7759/cureus.14561.
- Background: PubMed 33837832Lang SAJ, Bohn T, Barleben L, Pumberger M, Roll S, Buttner-Janz K. Advanced meta-analyses comparing the three surgical techniques total disc replacement, anterior stand-alone fusion and circumferential fusion regarding pain, function and complications up to 3 years to treat lumbar degenerative disc disease. Eur Spine J. 2021 Dec;30(12):3688-3701. doi: 10.1007/s00586-021-06784-6. Epub 2021 Apr 10.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
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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. This study is not recruiting at the moment.
Rashmi Mueller, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erector Spinae Block and Local infiltration with local anesthetic in people with Postoperative Delirium and Pain, Postoperative, run by Rashmi Mueller 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 13 Feb 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups (time frame: Change from pre-operation score to 1 day after surgery date). The study lists 2 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 NCT06199999, which also lists 26 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 13 Feb 2026.