Clinical trial NCT05494125: Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery
Official title: Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Operative Pain
Spine Surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
timeFrame: First 72 hours after surgery
Secondary outcomes:
measure: Duration of use and dose of opioid-iv-pca (if required)
timeFrame: First 72 hours after surgery
measure: Post-operative opioid consumption
timeFrame: From PACU arrival to 72 hours post surgery
measure: Numeric rating scale (NRS) pain scores: every 8 hours
timeFrame: Between PACU and 72 hours post surgery
measure: Quality of Recovery 15 (QoR15) scores
timeFrame: Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery
measure: Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
timeFrame: First 48 hours post surgery
measure: Total dose of ropivacaine delivered
timeFrame: First 48 hours post surgery
measure: Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)
timeFrame: First 48 hours post surgery
measure: Length of hospital stay
timeFrame: From PACU arrival to hospital discharge, up to 2 weeks
measure: Patient satisfaction scale with pain management and ESP catheters
timeFrame: First 72 hours, 14 days, and 42 days post surgery
measure: Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
timeFrame: 3 and 6 month post surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References: