ESP Block in MIS Lumbar Spine Surgery

October 1, 2025 updated by: Hospital for Special Surgery, New York

Erector Spinae Plane Block in Patients Undergoing Minimally Invasive Lumbar Spine Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sheeraz Qureshi, MD, MBA
  • Phone Number: 919-260-9699
  • Email: gangh@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
          • Sheeraz Qureshi, MD, MBA
          • Phone Number: 919-260-9699
          • Email: gangh@hss.edu
        • Sub-Investigator:
          • Patawut Bovonratwet, MD
        • Sub-Investigator:
          • Douglas Wetmore, MD
        • Principal Investigator:
          • Sheeraz Qureshi, MD, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP Block
Patients assigned to the "ESP Block" arm will receive an ESP block prior to the surgery.
Procedure: 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.
No Intervention: Control
Patients assigned to the "Control" group will not receive an ESP block prior to the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour oral morphine milligram equivalents (OMEs)
Time Frame: 24 hours postoperatively
The primary outcome of the study will be cumulative opioid use in the first 24 hours postoperatively in oral morphine milligram equivalents (OMEs) (24 hour period from PACU admission to POD1).
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only the PI, study coordinators listed on the IRB protocol, and co-investigators will have access to the IPD information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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