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NCT Number: NCT05856539

ESP Block in MIS Lumbar Spine Surgery

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Douglas Wetmore, MD

SUB_INVESTIGATOR

Patawut Bovonratwet, MD

SUB_INVESTIGATOR

Sheeraz Qureshi, MD, MBA

CONTACT

[email protected]

919-260-9699

Sheeraz Qureshi, MD, MBA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane (ESP) Block

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sheeraz Qureshi, MD, MBA

CONTACT

[email protected]

919-260-9699

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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