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ESP Block in MIS Lumbar Spine Surgery

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Enrolling

Conditions

Patients With Spinal Stenosis Indicated for MIS TLIF

Treatments

Procedure: Erector spinae plane (ESP) block

Study type

Interventional

Funder types

Other

Identifiers

NCT05856539
2021-1386

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

ESP Block
Experimental group
Description:
Patients assigned to the "ESP Block" arm will receive an ESP block prior to the surgery.
Treatment:
Procedure: Erector spinae plane (ESP) block
Control
No Intervention group
Description:
Patients assigned to the "Control" group will not receive an ESP block prior to the surgery.

Trial contacts and locations

1

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Central trial contact

Sheeraz Qureshi, MD, MBA

Data sourced from clinicaltrials.gov

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