Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

NCT ID: NCT06199999

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2026-12-30

Brief 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 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.

Conditions

Postoperative Delirium; Pain, Postoperative; Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group GA: General anesthesia only

This group receives general anesthesia only and surgical procedure will follow standard conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group ESP: Erector Spinae Block

This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Block

Intervention Type: PROCEDURE

General anesthesia with Erector Spinae Plane Block

Group LIA: Local Infiltration

This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.

Group Type: ACTIVE_COMPARATOR

Local infiltration with local anesthetic

Intervention Type: PROCEDURE

General anesthesia with local infiltration of local anesthetic:

Interventions

Erector Spinae Block

General anesthesia with Erector Spinae Plane Block

Intervention Type: PROCEDURE

Local infiltration with local anesthetic

General anesthesia with local infiltration of local anesthetic:

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age: Greater than 18 years but less than 80

2. Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery

3. Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)

4. No contraindication to local anesthetics or regional procedures.

Exclusion Criteria

1. Emergency surgery

2. Allergy to study medications

3. BMI less than 20 or greater than 50

4. Major liver or kidney dysfunction or other pre-existing major organ dysfunction

5. Revision surgery

6. 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)

7. Other sources of chronic pain (e.g. fibromyalgia)

8. Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use)

9. Pre-operative neurological deficits

10. Co-existing hematological disorders or deranged coagulation parameters

11. Significant psychiatric illnesses that impedes the subject's ability to provide informed consent

12. Language barrier

13. Vulnerable population (e.g. prisoners)

14. Pregnant females

15. History of recent myocardial infarction

16. History of recent cardiac stent procedure (within 3 months)

17. Cardiac ejection fraction < 30%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rashmi Mueller

OTHER

Sponsor Role: lead

Responsible Party

Rashmi Mueller

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rashmi Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Health Care Medical Center

Iowa City, Iowa, United States

Countries

United States

References

Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr.

Reference Type: BACKGROUND

PMID: 33716419 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20345866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27696373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34098376 (View on PubMed)

Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.

Reference Type: BACKGROUND

PMID: 14710509 (View on PubMed)

Etzioni 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.

Reference Type: BACKGROUND

PMID: 14627256 (View on PubMed)

Fineberg 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.

Reference Type: BACKGROUND

PMID: 23797502 (View on PubMed)

Forero 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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

Huang 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.

Reference Type: BACKGROUND

PMID: 35803754 (View on PubMed)

Hughey 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.

Reference Type: BACKGROUND

PMID: 20142356 (View on PubMed)

Inouye 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.

Reference Type: BACKGROUND

PMID: 23992774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32357842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34026377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33837832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14576554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33208089 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33983515 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32585193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28141603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28426530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27239384 (View on PubMed)

Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5.

Reference Type: BACKGROUND

PMID: 33032124 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32433277 (View on PubMed)

Susano MJ, Scheetz SD, Grasfield RH, Cheung D, Xu X, Kang JD, Smith TR, Lu Y, Groff MW, Chi JH, Crosby G, Culley DJ. Retrospective Analysis of Perioperative Variables Associated With Postoperative Delirium and Other Adverse Outcomes in Older Patients After Spine Surgery. J Neurosurg Anesthesiol. 2019 Oct;31(4):385-391. doi: 10.1097/ANA.0000000000000566.

Reference Type: BACKGROUND

PMID: 30531557 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32898243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34397527 (View on PubMed)

Other Identifiers

202201643

Identifier Type: -

Identifier Source: org_study_id