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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Patients will receive either liposomal bupivacaine as part of the ESPB .
This is the control group comparator as this is standard of care at the investigator's institution.
Opioid Use
Opioid Use in patient stay measured in morphine milligram equivalents
Time frame: 72 hours (standard inpatient stay)
Pain Report at Rest-Immediate postop
Pain as measured using Numeric Pain Scale (NPS) while patient is at rest immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)
Time frame: Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU).
Pain Report with activity-Immediate postop
Pain as measured using Numeric Pain Scale (NPS) while patient is active immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)
Time frame: 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.
Pain Report at Rest-Post op day 1
Pain as measured using Numeric Pain Scale (NPS) while patient is at rest 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).
Time frame: 24 hours post-op
Pain Report with activity-Post op day 1
Pain as measured using Numeric Pain Scale (NPS) with activity 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).
Time frame: 24 hours post-op
Pain Report at rest-at discharge
Pain as measured using Numeric Pain Scale (NPS) while patient is at rest at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).
Time frame: 72 hours post-op
Pain Report with activity-at discharge
Pain as measured using Numeric Pain Scale (NPS) with activity at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).
Time frame: 72 hours post-op
PACU recovery time
Time from entry into PACU to time patient is listed as recovered
Time frame: <5 hours post op
Patient Statisfcation
Based on Press Ganey Patient Satisfaction Survey. The minimum score is 0 (very poor) while the maximum score is 100 (very good).
Time frame: 10-14 days post-op
Patient reported outcomes score
Oswestry Disability Index (ODI) score. The minimum ODI score is 0 and represents minimal disability, while the maximum score of 100 represents the worst outcome - bed-bound significant disability.
Time frame: 3 months post-op
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