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The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801863
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Iyabo Muse, Montefiore Medical Center

Brief 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.

Condition or disease Intervention/treatment
Hip Arthropathy Regional Anesthesia Procedure: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375% Drug: Ropivacaine

Detailed Description:

Hypothesis:

The erector spinae plane block will decrease opioid requirements in patients undergoing hip arthroplasty as compared to patients that do not receive the block.

Primary Objective:

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.

Secondary Endpoints:

To evaluate the pain scores at discharge from PACU, at 2 hours post PACU discharge, at 24 hours and at 48 hours postoperative; to evaluate the sensory distribution of the block (T10-L5); to evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness

Design and methods This is a randomized, prospective study in patients receiving hip arthroplasty. Patients will be assigned to receive a lumbar erector spinae block versus no block. There will be no change in the primary anesthetic technique (spinal anesthesia with sedation) since these patients routinely get spinal anesthesia for hip arthroplasty. Consent for the study will be obtained in the preoperative area upon arrival for surgery. Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. Patients to receive a nerve block will receive mild sedation (1-2mg midazolam ± ≤100mcg fentanyl). All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.

Postoperatively, the PACU nurse will be asked to document pain scores according to the Visual Analog Scale (VAS) and total dose of opioids given. The distribution of the sensory block and motor weakness will be documented in the anesthesiologist's PACU discharge note. For patients that receive the block, the Physical therapist note will be assessed for any report of quadriceps muscle weakness (i.e., evidence of buckling while walking).

For postoperative data collection, opioid consumption totals and the pain scores at 2 hours post admission, at 24 hours and 48 hours post-procedure will be collected from the electronic medical record (EMR) as documented by nurses on the admitting floor. Additionally, the Acute Pain service, who rounds on all patients that receive nerve blocks, will make a note of the pain scores of the patient and any residual muscle weakness or decreased sensation at 24- and 48-hours post-procedure. All data will then be extracted from the EMR by the research assistant.

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace- a Randomized Controlled Study Comparing the 24-hour Opioid Requirements.
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 24, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ultrasound-guided Erector Spinae Block
Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.
Procedure: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%
Ultrasound-guided Erector Spinae Plane Block will be done at L4 interspace. Ropivacaine 0.375% will be used.

Drug: Ropivacaine
Using 0.375% Ropivacaine in the nerve block

No Ultrasound-guided Erector Spinae Block
Patients with no peripheral nerve block to serve as the control.



Primary Outcome Measures :
  1. Opioid Consumption in PACU and 24 hours post surgery [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. Pain scores at 2 hours post PACU discharge [ Time Frame: 2 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain ]
    To evaluate the pain scores at 2 hours post PACU discharge

  2. To evaluate the sensory distribution of the block (T10-L5). [ Time Frame: 2 hours post-surgery ]
    Will test for temperature difference using ice cube.

  3. To evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness [ Time Frame: 30 hours post-surgery ]
    Will have patient walk and Physical Therapist will assess for buckling of knee or potential falls while ambulating.

  4. Pain scores at 24 hours post PACU discharge [ Time Frame: 24 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain ]
    To evaluate the pain scores at 24 hours post PACU discharge

  5. Pain scores at 48 hours postoperative [ Time Frame: 48 hours post-surgery. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain ]
    To evaluate the pain scores at 48 hours postoperative.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing primary total hip replacement under neuraxial anesthesia
Criteria

Inclusion Criteria:

  • Patients undergoing primary hip arthroplasty
  • ASA 1, 2, and 3
  • Patients age ≥18 years

Exclusion Criteria:

  • Patient refusal
  • Inability to understand and sign consent
  • Infection at the injection site
  • Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
  • Contraindication or patient refusal to get spinal anesthesia
  • Thrombocytopenia (platelets < 100,000)
  • Coagulopathy (INR > 1.4)
  • Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery
  • ASA 4 and 5

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801863


Contacts
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Contact: Iyabo Muse, MD 718-920-4316 imuse@montefiore.org
Contact: Celina Joco 718-920-7178 cjoco@montefiore.org

Locations
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United States, New York
Montefiore Medical Center- Wakefield Campus Recruiting
Bronx, New York, United States, 10467
Contact: Iyabo Muse, MD    718-920-4316    imuse@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Iyabo Muse, MD Montefiore Medical Center
Publications:
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Responsible Party: Iyabo Muse, Assist. Professor, Dept of Anesthesiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03801863    
Other Study ID Numbers: 2018-9687
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iyabo Muse, Montefiore Medical Center:
Erector Spinae Plane Block
Ropivacaine
Ultrasound guided nerve block
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents