Patients With Spinal Stenosis Indicated for MIS TLIF
Conditions
Keywords
Erector spinae plane (ESP) block, Transforaminal lumbar interbody fusion (TLIF), Minimally invasive spine surgery, Lumbar spine, Spinal fusion
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.
Interventions
PROCEDUREErector spinae plane (ESP) block
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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to randomization (whether or not they received an ESP block preoperatively). Co-investigators will not be blinded as the anesthesiologist will need to perform the ESP block.
Intervention model description
This is a single-center, prospective, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactSheeraz Qureshi, MD, MBA
Outcome results
None listed