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
Overview
- Phase
- Phase 4
- Intervention
- PNB Bupivacaine
- Conditions
- Total Hip Arthroplasty
- Sponsor
- Mayo Clinic
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Maximum Postoperative Pain Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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®).
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.
Investigators
Rebecca L Johnson, MD
PI
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- •Patients presenting for unilateral primary total hip arthroplasty
- •Patients 18 years of age and older
Exclusion Criteria
- •Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- •History of long term use of daily opioids (\>1 months) with Oral Morphine Equivalent (OME) \>5mg/day
- •Body mass index (BMI) \> 40 kg/m2
- •Allergies to medications used in this study such as: fentanyl,hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin
- •Major systemic medical problems such as:
- •severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2
- •cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV
- •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
- •Impaired cognitive function or inability to understand the study protocol
- •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.).
Arms & Interventions
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.
Intervention: PNB Bupivacaine
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.
Intervention: Epinephrine
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.
Intervention: PAI Ropivacaine
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.
Intervention: Epinephrine
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.
Intervention: Ketorolac
PAI liposomal bupivacaine
Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.
Intervention: PAI liposomal bupivacaine
PAI liposomal bupivacaine
Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.
Intervention: Epinephrine
PAI liposomal bupivacaine
Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.
Intervention: Ketorolac
Outcomes
Primary Outcomes
Maximum Postoperative Pain Score
Time Frame: Post-Operative Day 1 (0600-1200)
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.
Secondary Outcomes
- Total Opioid Consumption During Hospitalization(Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2)