Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02242201
Collaborator
(none)
165
1
3
24
6.9

Study Details

Study Description

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®).

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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: PAI Ropivacaine
    Injection
    Other Names:
  • Naropin
  • Drug: Epinephrine
    Injection, weight-based dosage of 100 mcg - 300 mcg

    Drug: Ketorolac
    Injection, 30 mg
    Other Names:
  • Acuvail
  • Acular
  • Active Comparator: PAI liposomal bupivacaine

    Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.

    Drug: PAI liposomal bupivacaine
    Injection
    Other Names:
  • Exparel
  • Drug: Epinephrine
    Injection, weight-based dosage of 100 mcg - 300 mcg

    Drug: Ketorolac
    Injection, 30 mg
    Other Names:
  • Acuvail
  • Acular
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Postoperative Pain Score [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 Outcome Measures

    1. Total Opioid Consumption During Hospitalization [Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2]

      Measured in daily oral morphine equivalents (OME)

    Other Outcome Measures

    1. Hospital Length of Stay [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 [Baseline, 3 months]

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

    3. Post-Operative Pain Score [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    6. severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2

    7. cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV

    8. 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

    9. Impaired cognitive function or inability to understand the study protocol

    10. 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.).

    11. Previous contralateral hip replacement managed with regional or periarticular injection

    12. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota

    13. Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Rebecca Johnson, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebecca L Johnson, MD, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02242201
    Other Study ID Numbers:
    • 14-004183
    • UL1TR000135
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Apr 19, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. Posterior lumbar plexus block (PNB) Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. Periarticular infiltration (PAI) Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Period Title: Overall Study
    STARTED 55 55 55
    COMPLETED 51 54 54
    NOT COMPLETED 4 1 1

    Baseline Characteristics

    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine Total
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Total of all reporting groups
    Overall Participants 51 54 54 159
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.1
    (11.5)
    59.4
    (15.3)
    61.7
    (11.7)
    61.0
    (12.9)
    Sex: Female, Male (Count of Participants)
    Female
    25
    49%
    27
    50%
    28
    51.9%
    80
    50.3%
    Male
    26
    51%
    27
    50%
    26
    48.1%
    79
    49.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    51
    100%
    54
    100%
    54
    100%
    159
    100%
    Duration of surgery (minutes) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [minutes]
    91.4
    (24.0)
    88.1
    (23.2)
    88.4
    (28.3)
    89.2
    (25.2)
    Type of anesthetic (Count of Participants)
    General
    13
    25.5%
    10
    18.5%
    13
    24.1%
    36
    22.6%
    Spinal
    38
    74.5%
    44
    81.5%
    41
    75.9%
    123
    77.4%
    American Society of Anesthesiologists (ASA) Status (Count of Participants)
    I or II
    44
    86.3%
    41
    75.9%
    45
    83.3%
    130
    81.8%
    III
    7
    13.7%
    13
    24.1%
    9
    16.7%
    29
    18.2%
    BMI (kg/m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m2]
    30.0
    (6.0)
    30.1
    (6.0)
    30.2
    (5.4)
    30.1
    (5.8)

    Outcome Measures

    1. Primary Outcome
    Title Maximum Postoperative Pain Score
    Description 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.
    Time Frame Post-Operative Day 1 (0600-1200)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 51 54 54
    Median (Inter-Quartile Range) [units on a scale]
    3.0
    4.0
    3.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.103
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Secondary Outcome
    Title Total Opioid Consumption During Hospitalization
    Description Measured in daily oral morphine equivalents (OME)
    Time Frame Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2

    Outcome Measure Data

    Analysis Population Description
    For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group).
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 51 54 54
    Preoperative
    15
    15
    15
    Intraoperative
    10
    10
    10
    Postanesthesia Care Unit (PACU)
    0
    0
    0
    Post Operative Day (POD) 0 post PACU
    7.5
    15
    11.3
    POD 1
    22.5
    33.8
    15
    POD 2
    15
    15
    11.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments Preoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.948
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments Preoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.880
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Preoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.802
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments Intraoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.179
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments Intraoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.837
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Intraoperative
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.142
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.516
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.052
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments POD 0 post PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.840
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments POD 0 post PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.744
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments POD 0 post PACU
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.501
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments POD 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.358
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments POD 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.536
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments POD 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine
    Comments POD 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.313
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Liposomal Bupivacaine
    Comments POD 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.893
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments POD 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.232
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    3. Other Pre-specified Outcome
    Title Hospital Length of Stay
    Description Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.
    Time Frame Post-operative Day 1 through discharge (approximately 3 days)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 51 54 54
    Median (Inter-Quartile Range) [days]
    2
    2
    2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.772
    Comments
    Method Kruskal-Wallis
    Comments
    4. Other Pre-specified Outcome
    Title Change in Unipedal Stance Time
    Description Length of time in seconds a patient could stand on involved leg
    Time Frame Baseline, 3 months

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 54 51
    Baseline
    24.5
    30
    30
    3 months
    30
    30
    30
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Baseline
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.251
    Comments
    Method Regression, Cox
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments 3 month follow-up
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.300
    Comments
    Method Regression, Cox
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.113
    Comments
    Method Regression, Cox
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.147
    Comments
    Method Regression, Cox
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection PAI Liposomal Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.216
    Comments
    Method Regression, Cox
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.968
    Comments
    Method Regression, Cox
    Comments
    5. Other Pre-specified Outcome
    Title Post-Operative Pain Score
    Description 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.
    Time Frame 3 month follow-up

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 54 51
    Pain at rest
    0
    0
    0
    Pain with movement
    0
    1
    1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Pain at rest
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.776
    Comments
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Pain with movement
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.447
    Comments
    Method Kruskal-Wallis
    Comments
    6. Other Pre-specified Outcome
    Title Change in Short Form-36 (SF-36) Quality of Life Physical Component
    Description 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).
    Time Frame Baseline, 3 months

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 52 51
    Mean (Standard Deviation) [units on a scale]
    12.5
    (10.3)
    12.6
    (9.1)
    12.3
    (8.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.986
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PAI Liposomal Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    7. Other Pre-specified Outcome
    Title Change in Short Form-36 (SF-36) Quality of Life Mental Component
    Description 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).
    Time Frame Baseline, 3 months

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 52 51
    Mean (Standard Deviation) [units on a scale]
    2.2
    (9.5)
    2.6
    (9.4)
    3.0
    (9.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.898
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.112
    Comments
    Method t-test, 1 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PAI Ropivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.046
    Comments
    Method t-test, 1 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PAI Liposomal Bupivacaine
    Comments Baseline vs 3 months
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.026
    Comments
    Method t-test, 1 sided
    Comments
    8. Other Pre-specified Outcome
    Title Number of Participants Reporting Complications Since Surgery
    Description Complications were collected by telephone interview after surgery.
    Time Frame Post-operative Day 1 Through 3 - Month Follow-up

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 54 51
    Operative extremity neurologic changes
    1
    2%
    1
    1.9%
    2
    3.7%
    Wound infection
    0
    0%
    1
    1.9%
    1
    1.9%
    Fall requiring medical attention
    1
    2%
    2
    3.7%
    1
    1.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Operative extremity neurologic changes
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.843
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Wound infection
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.00
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Fall requiring medical attention
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.00
    Comments
    Method Fisher Exact
    Comments
    9. Other Pre-specified Outcome
    Title Number of Participants Reporting a NRS Pain Score Greater Than 3
    Description 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.
    Time Frame 3 month follow up

    Outcome Measure Data

    Analysis Population Description
    Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    Measure Participants 50 54 51
    Pain at rest
    0
    0%
    1
    1.9%
    1
    1.9%
    Pain with movement
    0
    0%
    4
    7.4%
    2
    3.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Pain at rest
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.00
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine
    Comments Pain with movement
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.167
    Comments
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
    Adverse Event Reporting Description The Anesthesia Clinical Research Unit (ACRU) not affiliated with the investigator team had continuous access to information regarding adverse outcomes and monitored quarterly reporting to the principal investigator. Participants were postoperatively monitored for adverse outcomes by the inpatient pain service (IPS) or surgical team.
    Arm/Group Title PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Arm/Group Description 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg
    All Cause Mortality
    PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/51 (0%) 0/54 (0%) 0/54 (0%)
    Serious Adverse Events
    PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/51 (0%) 0/54 (0%) 0/54 (0%)
    Other (Not Including Serious) Adverse Events
    PNB Bupivacaine PAI Ropivacaine PAI Liposomal Bupivacaine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/51 (0%) 3/54 (5.6%) 1/54 (1.9%)
    General disorders
    Fall 0/51 (0%) 0 0/54 (0%) 0 0/54 (0%) 0
    Infection 0/51 (0%) 0 0/54 (0%) 0 0/54 (0%) 0
    ICU admission 0/51 (0%) 0 3/54 (5.6%) 3 0/54 (0%) 0
    Rapid response team 0/51 (0%) 0 2/54 (3.7%) 2 0/54 (0%) 0
    Nervous system disorders
    Nerve Injury 0/51 (0%) 0 0/54 (0%) 0 0/54 (0%) 0
    Surgical and medical procedures
    Additional surgery 0/51 (0%) 0 0/54 (0%) 0 1/54 (1.9%) 1

    Limitations/Caveats

    PNB and PAI for total hip arthroplasty are highly technique dependent modalities and standardized delivery of PAI injections is less established than PNB.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Rebecca L. Johnson
    Organization Mayo Clinic
    Phone 507-266-2049
    Email Johnson.Rebecca1@mayo.edu
    Responsible Party:
    Rebecca L Johnson, MD, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02242201
    Other Study ID Numbers:
    • 14-004183
    • UL1TR000135
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Apr 19, 2018
    Last Verified:
    Mar 1, 2018