Clinical trial NCT06107660: Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion
Official title: Utility of Exparel Based Erector Spinae Plane Block for Elective 1 and 2 Level Posterior-based Lumbar Fusion: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spine Fusion
Anesthesia, Local
Keywords: Erector Spinae Block
Lumbar Spine
bupivacaine
Exparel
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants will be randomized to receive either a mixture of liposomal bupivacaine/ bupivacaine or standard bupivacaine with adjuncts for their ESPB.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are:

1. Can liposomal bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)?
2. Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication?

Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

Detailed description: The purpose of this study is to improve pain management for patients having spine fusion surgery. This aim will be achieved by evaluating how well liposomal bupivacaine (LB), an FDA approved numbing medication that can provide pain relief for up to 72 hours after surgery, works when used as a single dose in a regional block known as Erector Spinae Plane block (ESPB). ESPB is a regional anesthesia technique used to control pain after surgery by injecting numbing medication around the patient's back bones on both sides. The study will compare how well LB in ESPB works compared to the standard practice procedure, which involves administering the traditional numbing medication (bupivacaine) through the ESPB. These two medications will be evaluated in reducing postoperative opioid medication need to control postoperative pain, as the primary goal. This study seeks to understand whether an ESP block either with bupivacaine and stabilizing agents or using liposomal bupivacaine, reduces the total amount of opioid medication used postoperatively, reduces pain scores, and leads to better patient reported outcome scores, patient satisfaction, and reduced recovery time in the PACU. Should the investigator find that liposomal bupivacaine is not superior to bupivacaine with stabilizing agents, this information would prove useful in regards to analgesic options for this patient population and could lead to a substantial cost savings.

Eligibility criteria: Inclusion Criteria:

* Lumbar pathology requiring a single or two level elective posterior based (i.e. posterior or transforaminal approach) spine fusion with or without an interbody device.
* Surgical approach through either a midline or paramedian incision
* Primary fusion surgery, previous decompression surgery is acceptable
* American Society of Anesthesiologists (ASA) score of 1,2,or 3.

Exclusion Criteria:

* Patients currently on narcotic pain medication for pain management
* Patients with a history of illicit drug use
* Patients with neuromuscular disorders or neurological deficits (i.e. post polio or myasthenia gravis)
* Patients confined to a wheelchair for over 6 months
* Patients with fibromyalgia or other chronic pain disorder
* Patient with contraindications for use of the ESP block (i.e. local skin infection over the area of needle entry, or anaphylactic reaction to bupivacaine)
* Non-invasive surgical approaches
* Repeat or revision surgery
* Non-posterior spine surgical approaches (i.e. lateral, oblique, anterior, anterior and posterior approaches)
* Staged procedures
* Adjacent segment surgery
* Patients with a weight less than 40kg to avoid local anesthetic systematic toxicity.

Primary outcomes:
measure: Opioid Use
timeFrame: 72 hours (standard inpatient stay)
Secondary outcomes:
measure: Pain Report at Rest-Immediate postop
timeFrame: Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU).
measure: Pain Report with activity-Immediate postop
timeFrame: Patient is asked their pain level once they have been moved to their hospital room from the PACU. Typically this occurs within 5 hours of surgery.
measure: Pain Report at Rest-Post op day 1
timeFrame: 24 hours post-op
measure: Pain Report with activity-Post op day 1
timeFrame: 24 hours post-op
measure: Pain Report at rest-at discharge
timeFrame: 72 hours post-op
measure: Pain Report with activity-at discharge
timeFrame: 72 hours post-op
measure: PACU recovery time
timeFrame: <5 hours post op
measure: Patient Statisfcation
timeFrame: 10-14 days post-op
measure: Patient reported outcomes score
timeFrame: 3 months post-op
Other outcomes:
Locations:
Study officials:
affiliation: Hartford HealthCare
name: Heeren Makanji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makanji HS, Solomito MJ, Maffeo-Mitchell C, Esmende S, Finkel K. Utility of Erector Spinae Plane Blocks for Postoperative Pain Management and Opioid Reduction Following Lumbar Fusions. Clin Spine Surg. 2023 May 1;36(4):E131-E134. doi: 10.1097/BSD.0000000000001387. Epub 2022 Sep 13.