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

NCT03801863 | Terminated DMC FDA Drug

• 1 other identifier: 2018-9687
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthropathy; Regional Anesthesia

Keywords

Erector Spinae Plane Block; Ropivacaine; Ultrasound guided nerve block

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption in PACU and 24 hours post surgery

  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.

  24 hours

Secondary Outcomes (5)

• Pain scores at 2 hours post PACU discharge

  2 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain

• To evaluate the sensory distribution of the block (T10-L5).

  2 hours post-surgery

• To evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness

  30 hours post-surgery

• Pain scores at 24 hours post PACU discharge

  24 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain

• Pain scores at 48 hours postoperative

  48 hours post-surgery. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain

Study Arms (2)

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%; Drug: Ropivacaine

No Ultrasound-guided Erector Spinae Block

Patients with no peripheral nerve block to serve as the control.

Interventions

Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375% PROCEDURE

Ultrasound-guided Erector Spinae Plane Block will be done at L4 interspace. Ropivacaine 0.375% will be used.

Ultrasound-guided Erector Spinae Block

Ropivacaine DRUG

Using 0.375% Ropivacaine in the nerve block

Ultrasound-guided Erector Spinae Block

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing primary total hip replacement under neuraxial anesthesia

You may qualify if:

• Patients undergoing primary hip arthroplasty
• American Society of Anesthesiologists (ASA) Category 1, 2, and 3
• Patients age ≥18 years

You may not qualify if:

• 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 Category 4 and 5

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center- Wakefield Campus

The Bronx, New York, 10467, United States

Location

Related Publications (6)

• Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8.

  PMID: 25714040 BACKGROUND

• Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.

  PMID: 30092937 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.

  PMID: 29149734 BACKGROUND

• Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.

  PMID: 29522966 BACKGROUND

• Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.

  PMID: 19309064 BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Iyabo Muse, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 14, 2019
• Study Start: March 1, 2019
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)