ESP Block in MIS Lumbar Spine Surgery

Last updated: September 27, 2024
Sponsor: Hospital for Special Surgery, New York
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Spinal Stenosis

Treatment

Erector spinae plane (ESP) block

Clinical Study ID

NCT05856539
2021-1386
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-80

  • Patients scheduled for MIS TLIF (any level) with the principal investigator

  • ASA 1, 2, 3

Exclusion

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 Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Erector spinae plane (ESP) block
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
July 15, 2026

Study 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.

Connect with a study center

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

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