ESP Block in MIS Lumbar Spine Surgery

NCT ID: NCT05856539

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-07-15

Brief Summary

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This is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. This study will randomize patients into one of two groups: erector spinae plane (ESP) block and no ESP block.

Detailed Description

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Minimally invasive (MIS) spinal surgical procedures such as MIS transforaminal lumbar interbody fusion (TLIF) are being increasingly performed due to reduced morbidity. However, the mainstay for perioperative analgesia after these surgeries remains to be opioid pain medications, which have a number of associated adverse effects such as respiratory depression, hyperalgesia, and opioid habituation. Recently, the erector spinae plane (ESP) block has been introduced as an opioid-sparing regional anesthetic for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control. The proposed study aims to enroll patients in a double blind randomized controlled trial to undergo MIS TLIF with an ESP block or as conventional control group. Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained. Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, opioid-induced complications, time to opioid cessation, time to physical therapy clearance, length of stay, as well as other related outcomes will be performed.

Conditions

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Patients With Spinal Stenosis Indicated for MIS TLIF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single-center, prospective, randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be blinded to randomization (whether or not they received an ESP block preoperatively). Co-investigators will not be blinded as the anesthesiologist will need to perform the ESP block.

Study Groups

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ESP Block

Patients assigned to the "ESP Block" arm will receive an ESP block prior to the surgery.

Group Type EXPERIMENTAL

Erector spinae plane (ESP) block

Intervention Type PROCEDURE

ESP block is an opioid-sparing regional anesthetic involving bupivacaine and dexamethasone for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control.

Control

Patients assigned to the "Control" group will not receive an ESP block prior to the surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector spinae plane (ESP) block

ESP block is an opioid-sparing regional anesthetic involving bupivacaine and dexamethasone for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* Patients scheduled for MIS TLIF (any level) with the principal investigator
* ASA 1, 2, 3

Exclusion Criteria

* ASA 4 or higher
* BMI \>40
* Chronic opioid use (daily use for \> 3 months)
* Revision surgery, any history of previous lumbar spine surgery
* Allergy to any of the study medications
* Non-English speaking
* Chronic renal insufficiency or failure (creatinine \>2) or severe hepatic disease (cirrhosis, failure)
* Pregnancy
* Any concomitant surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sheeraz Qureshi, MD, MBA

Role: CONTACT

919-260-9699

Facility Contacts

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Sheeraz Qureshi, MD, MBA

Role: primary

919-260-9699

References

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De Rojas JO, Syre P, Welch WC. Regional anesthesia versus general anesthesia for surgery on the lumbar spine: a review of the modern literature. Clin Neurol Neurosurg. 2014 Apr;119:39-43. doi: 10.1016/j.clineuro.2014.01.016. Epub 2014 Jan 27.

Reference Type BACKGROUND
PMID: 24635923 (View on PubMed)

Dunn LK, Durieux ME, Nemergut EC. Non-opioid analgesics: Novel approaches to perioperative analgesia for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):79-89. doi: 10.1016/j.bpa.2015.11.002. Epub 2015 Nov 24.

Reference Type BACKGROUND
PMID: 27036605 (View on PubMed)

Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study. J Spinal Disord Tech. 2013 Aug;26(6):291-7. doi: 10.1097/BSD.0b013e318246b0a6.

Reference Type BACKGROUND
PMID: 23887076 (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)

Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

Reference Type BACKGROUND
PMID: 29913392 (View on PubMed)

Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

Reference Type BACKGROUND
PMID: 29980005 (View on PubMed)

Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.

Reference Type BACKGROUND
PMID: 30055991 (View on PubMed)

Abu Elyazed MM, Mostafa SF, Abdelghany MS, Eid GM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Open Epigastric Hernia Repair: A Prospective Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):235-240. doi: 10.1213/ANE.0000000000004071.

Reference Type BACKGROUND
PMID: 30801359 (View on PubMed)

Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.

Reference Type BACKGROUND
PMID: 30113699 (View on PubMed)

Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.

Reference Type BACKGROUND
PMID: 29794943 (View on PubMed)

Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.

Reference Type BACKGROUND
PMID: 29704223 (View on PubMed)

Cesur S, Yayik AM, Ozturk F, Ahiskalioglu A. Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. Cureus. 2018 Nov 16;10(11):e3603. doi: 10.7759/cureus.3603.

Reference Type BACKGROUND
PMID: 30680264 (View on PubMed)

Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15.

Reference Type BACKGROUND
PMID: 30424594 (View on PubMed)

Singh S, Chaudhary NK. Bilateral Ultasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery: A Case Series. J Neurosurg Anesthesiol. 2019 Jul;31(3):354. doi: 10.1097/ANA.0000000000000518. No abstract available.

Reference Type BACKGROUND
PMID: 29965831 (View on PubMed)

Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

Reference Type BACKGROUND
PMID: 31033625 (View on PubMed)

Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.

Reference Type BACKGROUND
PMID: 30853517 (View on PubMed)

Other Identifiers

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2021-1386

Identifier Type: -

Identifier Source: org_study_id

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