Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

Hartford Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Spine Fusion; Anesthesia, Local

Treatments: Drug: Bupivacaine; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06107660

HHC-2023-0204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Study Group

Experimental group

Description:

Patients in the study Group will receive 20ml 1.3% Liposomal bupivacaine (Exparel®) dose of 266mg with 40 ml of 0.25% bupivacaine. The local anesthetic solution will be administered bilaterally in the plane between the lumber transverse process and the erector spinae muscles to block the dorsal and ventral rami of the spinal nerves under ultrasound guidance using a standard block needled. A total of 60 ml solution will be injected -30 ml on each side of the spinal column.

Treatment:

Drug: Liposomal bupivacaine

Control Group

Active Comparator group

Description:

Patients in the control group will receive 60ml of 0.25% bupivacaine with 5 mg preservative free dexamethasone and 150 mcg Epinephrine (in a 1:400,000 dilution). The local anesthetic solution will be administered bilaterally in the plane between the lumber transverse process and the erector spinae muscles to block the dorsal and ventral rami of the spinal nerves under ultrasound guidance using a standard block needled. A total of 60 ml solution will be injected -30 ml on each side of the spinal column.

Treatment:

Drug: Bupivacaine