Erector Spinae Block for Spine Surgery

Phase 4

Terminated

Brief Summary: This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

Detailed Description: This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine and Bupivacaine	Liposomal bupivacaine	liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
Bupivacaine only	Bupivacaine	bupivacaine 0.25% in ESP blocks
Liposomal Bupivacaine and Bupivacaine	Bupivacaine	liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks

Primary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption During First 72 Hours	12 hours, 24 hours, 48 hours, 72 hours	The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours

Secondary Outcome Measures

Name	Time	Method
Time to Ambulation	average 26-27 hours	Time to ambulation in hours
Change in Pain Score	up to 12 weeks	Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.
Quality of Recovery (QOR 15)	72 hours	Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.
Number of Participants With Postoperative Nausea/Vomiting (PONV)	in PACU (4 hours)	Number of participants with postoperative nausea/vomiting (PONV) in PACU
Hospital Length of Stay	average 72 hours	Hospital length of stay (LOS)