Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242201
• Other study ID #: 14-004183
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2014
• Last updated: March 21, 2018
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Drug:
• PNB Bupivacaine
Infusion
• PAI Ropivacaine
Injection
• PAI liposomal bupivacaine
Injection
• Epinephrine
Injection, weight-based dosage of 100 mcg - 300 mcg
• Ketorolac
Injection, 30 mg

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Change in Unipedal Stance Time	Length of time in seconds a patient could stand on involved leg	Baseline, 3 months
Other	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
Other	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
Other	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
Other	Number of Participants Reporting Complications Since Surgery	Complications were collected by telephone interview after surgery.	Post-operative Day 1 Through 3 - Month Follow-up
Other	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
Primary	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	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