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

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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

Tracking Information
First Submitted Date January 5, 2019
First Posted Date January 14, 2019
Last Update Posted Date April 1, 2020
Actual Study Start Date March 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2019)
  • 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
  • To evaluate the sensory distribution of the block (T10-L5). [ Time Frame: 2 hours post-surgery ]
    Will test for temperature difference using ice cube.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: January 9, 2019)
  • Pain scores at 2 hours post PACU discharge [ Time Frame: 2 hours ]
    To evaluate the pain scores at 2 hours post PACU discharge
  • To evaluate the sensory distribution of the block (T10-L5). [ Time Frame: 2 hours post-surgery ]
    Will test for temperature difference using ice cube.
  • 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.
  • Pain scores at 24 hours post PACU discharge [ Time Frame: 24 hours ]
    To evaluate the pain scores at 24 hours post PACU discharge
  • Pain scores at 48 hours postoperative [ Time Frame: 48 hours post-surgery ]
    To evaluate the pain scores at 48 hours postoperative.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace
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.
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients undergoing primary total hip replacement under neuraxial anesthesia
Condition
  • Hip Arthropathy
  • Regional Anesthesia
Intervention
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • Procedure: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%
    • Drug: Ropivacaine
  • No Ultrasound-guided Erector Spinae Block
    Patients with no peripheral nerve block to serve as the control.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 9, 2019)
74
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 24, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Iyabo Muse, MD 718-920-4316 imuse@montefiore.org
Contact: Celina Joco 718-920-7178 cjoco@montefiore.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03801863
Other Study ID Numbers 2018-9687
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Iyabo Muse, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Iyabo Muse, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date March 2020