Post Operative Pain, Spine Surgery
Conditions
Brief summary
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.
Interventions
OTHERRopivacaine
Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
OTHERPlacebo
Patients will receive a continuous infusion of saline solution through bilateral ESP catheters
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of use and dose of opioid-iv-pca (if required) | First 72 hours after surgery | Measured in morphine equivalents daily |
| Post-operative opioid consumption | From PACU arrival to 72 hours post surgery | Measured in morphine equivalents daily |
| Numeric rating scale (NRS) pain scores: every 8 hours | Between PACU and 72 hours post surgery | Scale of 0-10, 0 being no pain, 10 being the worst pain possible |
| Quality of Recovery 15 (QoR15) scores | Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery | 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). |
| Length of hospital stay | From PACU arrival to hospital discharge, up to 2 weeks | Measured in days after surgery |
| Total dose of ropivacaine delivered | First 48 hours post surgery | Measured in mg/kg/hr |
| Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone) | First 48 hours post surgery | If the patient ever had any of the events |
| Patient satisfaction scale with pain management and ESP catheters | First 72 hours, 14 days, and 42 days post surgery | Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied) |
| Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery | 3 and 6 month post surgery | Measured with a 7-item questionnaire to assess chronic pain and opioid use |
| Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement | First 48 hours post surgery | Measured in days after placement |
Countries
United States
Outcome results
None listed