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Completed

NCT Number: NCT02242201

Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

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®).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).
  • Previous contralateral hip replacement managed with regional or periarticular injection
  • Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
  • Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)

Treatment and study plan

PNB Bupivacaine

Drug

Infusion

Other names: Marcaine

PAI Ropivacaine

Drug

Injection

Other names: Naropin

PAI liposomal bupivacaine

Drug

Injection

Other names: Exparel

Epinephrine

Drug

Injection, weight-based dosage of 100 mcg - 300 mcg

Ketorolac

Drug

Injection, 30 mg

Other names: Acuvail, Acular

Primary outcomes

  1. 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

  1. Total Opioid Consumption During Hospitalization

    Time frame: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2

    Measured in daily oral morphine equivalents (OME)

Other outcomes

  1. Hospital Length of Stay

    Time frame: Post-operative Day 1 through discharge (approximately 3 days)

    Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.

  2. Change in Unipedal Stance Time

    Time frame: Baseline, 3 months

    Length of time in seconds a patient could stand on involved leg

  3. Post-Operative Pain Score

    Time frame: 3 month follow-up

    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.

  4. Change in Short Form-36 (SF-36) Quality of Life Physical Component

    Time frame: Baseline, 3 months

    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).

  5. Change in Short Form-36 (SF-36) Quality of Life Mental Component

    Time frame: Baseline, 3 months

    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).

  6. Number of Participants Reporting Complications Since Surgery

    Time frame: Post-operative Day 1 Through 3 - Month Follow-up

    Complications were collected by telephone interview after surgery.

  7. Number of Participants Reporting a NRS Pain Score Greater Than 3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel&#174;) on Patients Undergoing Total Hip Arthroplasty

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2014
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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