ESP Block in MIS Lumbar Spine Surgery

Not Applicable

Recruiting

• Conditions: Patients With Spinal Stenosis Indicated for MIS TLIF
• Interventions: Procedure: Erector spinae plane (ESP) block

• Registration Number: NCT05856539
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Study Start: 2023-05-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	Erector spinae plane (ESP) block	Patients assigned to the "ESP Block" arm will receive an ESP block prior to the surgery.

Primary Outcome Measures

Name	Time	Method
24-hour oral morphine milligram equivalents (OMEs)	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).

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States