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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Patients will receive either liposomal bupivacaine as part of the ESPB . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Opioid Use in patient stay measured in morphine milligram equivalents | 72 hours (standard inpatient stay) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heeren Makanji, MD | Contact | 860-549-8252 | Heeren.Makanji@hhchealth.org | |
| Matthew Solomito, PhD | Contact | 860-972-5656 | matthew.solomito@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Heeren Makanji, MD | Hartford HealthCare | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36097343 | Background | 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. |
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No individual participant data will be shared as part of this study.
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Enrolled participants will be randomized to receive either a mixture of liposomal bupivacaine/ bupivacaine or standard bupivacaine with adjuncts for their ESPB.
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The patient, orthopedic surgeon (investigator or care provider), and outcome assessor performing data analysis will be blinded to this study. The regional anesthesia block is performed prior to surgical incision without the surgeon present, and thus the surgeon will be blinded to which formulation was provided. The patient will be informed that they are receiving a block but will not be informed until data collection is complete at the 3 month mark as to which group they were part of.
Non-blinded Parties: Due to differences in the physical appearance it is impossible to blind the anesthesia team (attending and fellow) performing the block, as the standard block is clear while the Exparel formulation is milky. However, after the regional block has been performed the regional team will have no further contact with the patient as per standard practice, and thus maintaining a separation between those blinded and not.
| Bupivacaine | Drug | This is the control group comparator as this is standard of care at the investigator's institution. |
|
| 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) | 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). | 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). | 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). | 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). | 72 hours post-op |
| PACU recovery time | Time from entry into PACU to time patient is listed as recovered | <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). | 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. | 3 months post-op |
| D000588 |
| Amines |