Clinical trial NCT05856539: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour oral morphine milligram equivalents (OMEs)
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
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