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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
10
Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
Patients will receive a continuous infusion of saline solution through bilateral ESP catheters
Hospital for Special Surgery
New York, New York, United States
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
Time frame: First 72 hours after surgery
Duration of use and dose of opioid-iv-pca (if required)
Measured in morphine equivalents daily
Time frame: First 72 hours after surgery
Post-operative opioid consumption
Measured in morphine equivalents daily
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: First 48 hours post surgery
Total dose of ropivacaine delivered
Measured in mg/kg/hr
Time frame: 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
Time frame: First 48 hours post surgery
Length of hospital stay
Measured in days after surgery
Time frame: 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)
Time frame: 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
Time frame: 3 and 6 month post surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.