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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.
Treatment arms include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Block | Procedure | General anesthesia with Erector Spinae Plane Block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change from pre-operation score to 1 day after surgery date |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for all groups:
Exclusion Criteria for all groups:
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Mueller, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Health Care Medical Center | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27696373 | Background | 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. | |
| 34098376 | Background | Dunne 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. |
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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.
Individual participant data (IPD) will be available for sharing immediately after publication and ending 5 years following article publication.
Individual participant data (IPD) will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D010149 | Pain, Postoperative |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Local infiltration with local anesthetic | Procedure | General anesthesia with local infiltration of local anesthetic: |
|
| Change from pre-operation score to 3 days after surgery date |
| 14710509 | Background | Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14. |
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| 32357842 | Background | Kendall 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. |
| 34026377 | Background | Kumar 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. |
| 33837832 | Background | Lang 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. |
| 14576554 | Background | Leslie 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. |
| 33208089 | Background | Li 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. |
| 33983515 | Background | Ma 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. |
| 32585193 | Background | Mukherjee I. Invited commentary on "Effects of erector spinae plane block on postoperative pain and side-effects in adult patients underwent surgery: A systematic review and meta-analysis of randomized controlled trials". Int J Surg. 2020 Aug;80:35. doi: 10.1016/j.ijsu.2020.06.028. Epub 2020 Jun 22. No abstract available. |
| 28141603 | Background | Nazemi AK, Gowd AK, Carmouche JJ, Kates SL, Albert TJ, Behrend CJ. Prevention and Management of Postoperative Delirium in Elderly Patients Following Elective Spinal Surgery. Clin Spine Surg. 2017 Apr;30(3):112-119. doi: 10.1097/BSD.0000000000000467. |
| 28426530 | Background | Perera AP, Chari A, Kostusiak M, Khan AA, Luoma AM, Casey ATH. Intramuscular Local Anesthetic Infiltration at Closure for Postoperative Analgesia in Lumbar Spine Surgery: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2017 Jul 15;42(14):1088-1095. doi: 10.1097/BRS.0000000000001443. |
| 27239384 | Background | Rizk P, Morris W, Oladeji P, Huo M. Review of Postoperative Delirium in Geriatric Patients Undergoing Hip Surgery. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):100-5. doi: 10.1177/2151458516641162. Epub 2016 Apr 18. |
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| 20345866 | Background | Rudolph JL, Inouye SK, Jones RN, Yang FM, Fong TG, Levkoff SE, Marcantonio ER. Delirium: an independent predictor of functional decline after cardiac surgery. J Am Geriatr Soc. 2010 Apr;58(4):643-9. doi: 10.1111/j.1532-5415.2010.02762.x. Epub 2010 Mar 22. |
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| 32433277 | Background | Soffin EM, Beckman JD, Tseng A, Zhong H, Huang RC, Urban M, Guheen CR, Kim HJ, Cammisa FP, Nejim JA, Schwab FJ, Armendi IF, Memtsoudis SG. Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery. Anesthesiology. 2020 Aug;133(2):350-363. doi: 10.1097/ALN.0000000000003346. |
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| 32898243 | Background | Susano MJ, Grasfield RH, Friese M, Rosner B, Crosby G, Bader AM, Kang JD, Smith TR, Lu Y, Groff MW, Chi JH, Grodstein F, Culley DJ. Brief Preoperative Screening for Frailty and Cognitive Impairment Predicts Delirium after Spine Surgery. Anesthesiology. 2020 Dec 1;133(6):1184-1191. doi: 10.1097/ALN.0000000000003523. |
| 34397527 | Background | Waelkens P, Alsabbagh E, Sauter A, Joshi GP, Beloeil H; PROSPECT Working group * * of the European Society of Regional Anaesthesia and Pain therapy (ESRA). Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021 Sep 1;38(9):985-994. doi: 10.1097/EJA.0000000000001448. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |