Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery
- Conditions
- Spine SurgeryPost Operative Pain
- Registration Number
- NCT05494125
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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).
Total dose of ropivacaine delivered First 48 hours post surgery Measured in mg/kg/hr
Length of hospital stay From PACU arrival to hospital discharge, up to 2 weeks Measured in days after surgery
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
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States
Hospital for Special Surgery🇺🇸New York, New York, United States