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ESP Block in MIS Lumbar Spine Surgery

Primary Purpose

Patients With Spinal Stenosis Indicated for MIS TLIF

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Erector spinae plane (ESP) block

About this trial

This is an interventional treatment trial for Patients With Spinal Stenosis Indicated for MIS TLIF focused on measuring Erector spinae plane (ESP) block, Transforaminal lumbar interbody fusion (TLIF), Minimally invasive spine surgery, Lumbar spine, Spinal fusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital for Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESP Block

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

24-hour oral morphine milligram equivalents (OMEs)

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05856539

First Posted

May 4, 2023

Last Updated

September 13, 2023

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT05856539

Brief Title

ESP Block in MIS Lumbar Spine Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2023 (Actual)

Primary Completion Date

July 15, 2026 (Anticipated)

Study Completion Date

July 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Spinal Stenosis Indicated for MIS TLIF

Keywords

Erector spinae plane (ESP) block, Transforaminal lumbar interbody fusion (TLIF), Minimally invasive spine surgery, Lumbar spine, Spinal fusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ESP Block

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane (ESP) block

Intervention Description

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.

Primary Outcome Measure Information:

Title

24-hour oral morphine milligram equivalents (OMEs)

Description

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).

Time Frame

24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheeraz Qureshi, MD, MBA

Phone

919-260-9699

gangh@hss.edu

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheeraz Qureshi, MD, MBA

Phone

919-260-9699

gangh@hss.edu

First Name & Middle Initial & Last Name & Degree

Patawut Bovonratwet, MD

First Name & Middle Initial & Last Name & Degree

Douglas Wetmore, MD

First Name & Middle Initial & Last Name & Degree

Sheeraz Qureshi, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

24635923

Citation

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Citation

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ESP Block in MIS Lumbar Spine Surgery

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