Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel®) on Patients Undergoing Total Hip Arthroplasty

Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Drug: PNB Bupivacaine; Drug: Epinephrine; Drug: PAI Ropivacaine; Drug: Ketorolac; Drug: PAI liposomal bupivacaine

Detailed Description

Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.

Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
2. Patients presenting for unilateral primary total hip arthroplasty
3. Patients 18 years of age and older

Exclusion Criteria:

1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
2. History of long term use of daily opioids (>1 months) with Oral Morphine Equivalent (OME) >5mg/day
3. Body mass index (BMI) > 40 kg/m2
4. Allergies to medications used in this study such as: fentanyl,hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin

5. Major systemic medical problems such as:

   1. severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
   2. cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV
   3. severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
6. Impaired cognitive function or inability to understand the study protocol
7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
8. Previous contralateral hip replacement managed with regional or periarticular injection
9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
10. Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PNB Bupivacaine; Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.	Drug: PNB Bupivacaine; Infusion; Other Names: Marcaine; Drug: Epinephrine; Injection, weight-based dosage of 100 mcg - 300 mcg
Active Comparator: PAI Ropivacaine; Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.	Drug: Epinephrine; Injection, weight-based dosage of 100 mcg - 300 mcg; Drug: PAI Ropivacaine; Injection; Other Names: Naropin; Drug: Ketorolac; Injection, 30 mg; Other Names: Acular; Acuvail
Active Comparator: PAI liposomal bupivacaine; Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.	Drug: Epinephrine; Injection, weight-based dosage of 100 mcg - 300 mcg; Drug: Ketorolac; Injection, 30 mg; Other Names: Acular; Acuvail; Drug: PAI liposomal bupivacaine; Injection; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Postoperative Pain Score	Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.	Post-Operative Day 1 (0600-1200)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption During Hospitalization	Measured in daily oral morphine equivalents (OME)	Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.	Post-operative Day 1 through discharge (approximately 3 days)
Change in Unipedal Stance Time	Length of time in seconds a patient could stand on involved leg	Baseline, 3 months
Post-Operative Pain Score	Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.	3 month follow-up
Change in Short Form-36 (SF-36) Quality of Life Physical Component	Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).	Baseline, 3 months
Change in Short Form-36 (SF-36) Quality of Life Mental Component	Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).	Baseline, 3 months
Number of Participants Reporting Complications Since Surgery	Complications were collected by telephone interview after surgery.	Post-operative Day 1 Through 3 - Month Follow-up
Number of Participants Reporting a NRS Pain Score Greater Than 3	Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.	3 month follow up

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Rebecca Johnson, MD, Mayo Clinic

Publications and helpful links

General Publications

• Johnson RL, Amundson AW, Abdel MP, Sviggum HP, Mabry TM, Mantilla CB, Schroeder DR, Pagnano MW, Kopp SL. Continuous Posterior Lumbar Plexus Nerve Block Versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Total Hip Arthroplasty: A Three-Arm Randomized Clinical Trial. J Bone Joint Surg Am. 2017 Nov 1;99(21):1836-1845. doi: 10.2106/JBJS.16.01305.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 13, 2014
• First Submitted That Met QC Criteria: September 13, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ketorolac; Bupivacaine; Ropivacaine; Epinephrine
• Other Study ID Numbers: 14-004183; UL1TR000135 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes