Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03801863
Study type Observational
Source Montefiore Medical Center
Contact
Status Terminated
Phase
Start date March 1, 2019
Completion date January 26, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Terminated NCT02846610 - Registry for Acute Pain Treatment
Completed NCT03679897 - Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block Phase 4
Recruiting NCT06014749 - Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Terminated NCT03500744 - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery N/A
Completed NCT05160298 - Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery Phase 2
Recruiting NCT06121726 - Predictive Factors for the Effectiveness of the Ilioinguinal Iliohypogastric Nerve Block for Hernia Surgery
Completed NCT04549090 - Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
Completed NCT05286190 - Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair N/A
Completed NCT02200016 - Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery Phase 4
Recruiting NCT06089798 - Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
Not yet recruiting NCT06115720 - Consent in Anaesthesia N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT05344105 - Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block N/A
Completed NCT02950558 - Anesthesia for Pain After Ankle Fracture Surgery Phase 4
Completed NCT05351151 - Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks N/A
Completed NCT03117894 - PECS-2 for Breast Surgery N/A