Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

Study Overview
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Brief Summary
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Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.

Official Title
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Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial

Conditions
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Post Operative Pain, Spine Surgery

Intervention / Treatment
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* Other: Ropivacaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Presenting for elective multilevel (>2 spinal levels) spinal fusion Lumbar, thoracic, and thoracolumbar procedures included Posterior surgical approach Willing and able to follow the study protocol Able to provide informed consent Exclusion Criteria: Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months) Daily gabapentin/pregabalin use for longer than 3 months Prior spine surgery at the index level Allergy or contraindication (including renal, liver disease) to included study medications Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP Catheters with Ropivacaine 0.2%<br> | Other: Ropivacaine<br>* Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters<br>|
| Placebo Comparator: ESP Catheters with Saline Solution<br> | Other: Placebo<br>* Patients will receive a continuous infusion of saline solution through bilateral ESP catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA) |  | First 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of use and dose of opioid-iv-pca (if required) | Measured in morphine equivalents daily | First 72 hours after surgery | 
| Post-operative opioid consumption | Measured in morphine equivalents daily | From PACU arrival to 72 hours post surgery | 
| Numeric rating scale (NRS) pain scores: every 8 hours | Scale of 0-10, 0 being no pain, 10 being the worst pain possible | Between PACU and 72 hours post surgery | 
| Quality of Recovery 15 (QoR15) scores | The Quality of Recovery 15 (QoR15) is a 15-item questionnaire which assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. It has a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). | Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery | 
| Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement | Measured in days after placement | First 48 hours post surgery | 
| Total dose of ropivacaine delivered | Measured in mg/kg/hr | First 48 hours post surgery | 
| Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone) | If the patient ever had any of the events | First 48 hours post surgery | 
| Length of hospital stay | Measured in days after surgery | From PACU arrival to hospital discharge, up to 2 weeks | 
| Patient satisfaction scale with pain management and ESP catheters | Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied) | First 72 hours, 14 days, and 42 days post surgery | 
| Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery | Measured with a 7-item questionnaire to assess chronic pain and opioid use | 3 and 6 month post surgery |