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Unanticipated adverse events occurred in 2 participants
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP Catheters with Ropivacaine 0.2% | Experimental |
| |
| ESP Catheters with Saline Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Other | Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192785 | Derived | Amoroso K, Hughes AP, Sama AA, Cammisa FP, Shue J, Soffin EM. Continuous erector spinae plane catheters leading to unwanted neuraxial spread after spinal fusion surgery: a report of two cases from a terminated prospective randomized clinical trial. Reg Anesth Pain Med. 2023 Sep;48(9):478-481. doi: 10.1136/rapm-2023-104587. Epub 2023 May 16. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Other | Patients will receive a continuous infusion of saline solution through bilateral ESP catheters |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |