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NCT03801863 · ClinicalTrials.gov registry record
The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace
A clinical trial, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- 65
- Enrollment target
NCT03801863: Clinical Trial study, sponsored by Montefiore Medical Center.
NCT03801863 is a clinical trial that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801863 was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- 65 participants
- Enrollment target
Study Summary
Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.2 Moreover; optimal pain management can reduce the duration of hospitalization and the risk of adverse events, such as deep vein thrombus. The use of regional anesthesia reduces the postoperative opioid requirement, thereby decreasing the degree to which patients suffer the side effects of opioids, namely sedation and constipation, and less frequently nausea, vomiting, respiratory depression, pruritus, and retention. In the past, femoral nerve block, fascia iliaca compartment block, lumbar plexus block and the quadratus lumborum block have been shown efficacious for pain relief for hip arthroplasty. However there are several risk factors such as quadricep weakness and difficulty of the block that causes a limitation in the used of this blocks. Recently, the erector spinae plane block has been introduced as an alternative to the blocks above. This block was first described in the literature in 2016 when it was used to treat chronic neuropathic thoracic pain. Since then, there have been studies demonstrating its efficacy with a thoracic approach for analgesia in breast surgery and rib fractures.9 Only two case reports to date have demonstrated a lumbar approach to achieve analgesia for hip arthroplasty.10,11 The purpose of the study is to determine whether or not a lumbar erector spinae plane block is effective at improving postoperative pain in patients receiving hip arthroplasty.
Primary Outcome
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
Interventions
- DRUG Ropivacaine
- PROCEDURE Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2022-01-26 |
Why NCT03801863 stopped before completion
NCT03801863 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Ropivacaine is the first listed.
NCT03801863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801863 about?
NCT03801863 is a clinical study titled "The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace". Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general ane...
What is the current status of trial NCT03801863?
This trial is currently terminated. The enrollment target is 65 participants. The study started on 2019-03-01. Estimated completion is 2022-01-26.
What interventions are being tested in trial NCT03801863?
The interventions under investigation include: Ropivacaine (DRUG), Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375% (PROCEDURE).
Who is sponsoring clinical trial NCT03801863?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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