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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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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®).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNB Bupivacaine | Active Comparator | 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. |
|
| PAI Ropivacaine | Active Comparator | 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 liposomal bupivacaine | Active Comparator | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNB Bupivacaine | Drug | Infusion |
|
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Johnson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29088038 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Posterior lumbar plexus block (PNB) Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg |
| FG001 | 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. Periarticular infiltration (PAI) Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
| FG002 | PAI Liposomal Bupivacaine | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg |
| BG001 | PAI Ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Post-Operative Day 1 (0600-1200) |
|
Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment |
PNB and PAI for total hip arthroplasty are highly technique dependent modalities and standardized delivery of PAI injections is less established than PNB.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca L. Johnson | Mayo Clinic | 507-266-2049 | Johnson.Rebecca1@mayo.edu |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| PAI Ropivacaine | Drug | Injection |
|
|
| PAI liposomal bupivacaine | Drug | Injection |
|
|
| Epinephrine | Drug | Injection, weight-based dosage of 100 mcg - 300 mcg |
|
| Ketorolac | Drug | Injection, 30 mg |
|
|
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 |
| changed surgical procedure |
|
| postponed surgery |
|
| preoperative opioid consumption |
|
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 |
| BG002 | PAI Liposomal Bupivacaine | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of surgery | Mean | Standard Deviation | minutes |
|
| Type of anesthetic | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) Status | The ASA Physical Status Classification System assesses the fitness of patients prior to surgery. It defines an ASA I as a normal healthy patient, ASA II as a patient with mild systemic disease, and ASA III as a patient with severe systemic disease. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG002 | PAI Liposomal Bupivacaine | 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 |
|
|
|
| Secondary | Total Opioid Consumption During Hospitalization | Measured in daily oral morphine equivalents (OME) | 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). | Posted | Median | Inter-Quartile Range | Oral morphine equivalent in milligrams | Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2 |
|
|
|
|
| Other Pre-specified | Hospital Length of Stay | Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions. | Posted | Median | Inter-Quartile Range | days | Post-operative Day 1 through discharge (approximately 3 days) |
|
|
|
|
| Other Pre-specified | Change in Unipedal Stance Time | Length of time in seconds a patient could stand on involved leg | Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Median | Inter-Quartile Range | seconds | Baseline, 3 months |
|
|
|
|
| Other Pre-specified | 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. | Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Median | Inter-Quartile Range | units on a scale | 3 month follow-up |
|
|
|
|
| Other Pre-specified | 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). | Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
|
|
|
|
| Other Pre-specified | 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). | Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
|
|
|
|
| Other Pre-specified | Number of Participants Reporting Complications Since Surgery | Complications were collected by telephone interview after surgery. | Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Count of Participants | Participants | Post-operative Day 1 Through 3 - Month Follow-up |
|
|
|
|
| Other Pre-specified | 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. | Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. | Posted | Count of Participants | Participants | 3 month follow up |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | 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. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | 0 | 54 | 0 | 54 | 3 | 54 |
| EG002 | PAI Liposomal Bupivacaine | 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 | 0 | 54 | 0 | 54 | 1 | 54 |
| Nerve Injury | Nervous system disorders | Systematic Assessment |
|
| Infection | General disorders | Systematic Assessment |
|
| ICU admission | General disorders | Systematic Assessment |
|
| Rapid response team | General disorders | Systematic Assessment |
|
| Additional surgery | Surgical and medical procedures | Systematic Assessment |
|
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Spinal |
|
| III |
|
| Intraoperative |
|
|
| Postanesthesia Care Unit (PACU) |
|
|
| Post Operative Day (POD) 0 post PACU |
|
|
| POD 1 |
|
|
| POD 2 |
|
|
| 0.880 |
| Superiority |
| Preoperative | Wilcoxon (Mann-Whitney) | 0.802 | Superiority |
| Intraoperative | Wilcoxon (Mann-Whitney) | 0.179 | Superiority |
| Intraoperative | Wilcoxon (Mann-Whitney) | 0.837 | Superiority |
| Intraoperative | Wilcoxon (Mann-Whitney) | 0.142 | Superiority |
| PACU | Wilcoxon (Mann-Whitney) | 0.010 | Superiority |
| PACU | Wilcoxon (Mann-Whitney) | 0.516 | Superiority |
| PACU | Wilcoxon (Mann-Whitney) | 0.052 | Superiority |
| POD 0 post PACU | Wilcoxon (Mann-Whitney) | 0.840 | Superiority |
| POD 0 post PACU | Wilcoxon (Mann-Whitney) | 0.744 | Superiority |
| POD 0 post PACU | Wilcoxon (Mann-Whitney) | 0.501 | Superiority |
| POD 1 | Wilcoxon (Mann-Whitney) | 0.358 | Superiority |
| POD 1 | Wilcoxon (Mann-Whitney) | 0.536 | Superiority |
| POD 1 | Wilcoxon (Mann-Whitney) | 0.110 | Superiority |
| POD 2 | Wilcoxon (Mann-Whitney) | 0.313 | Superiority |
| POD 2 | Wilcoxon (Mann-Whitney) | 0.893 | Superiority |
| POD 2 | Wilcoxon (Mann-Whitney) | 0.232 | Superiority |
|
| 0.300 |
| Superiority |
| Baseline vs 3 months | Regression, Cox | 0.113 | Superiority |
| Baseline vs 3 months | Regression, Cox | 0.147 | Superiority |
| Baseline vs 3 months | Regression, Cox | 0.216 | Superiority |
| Baseline vs 3 months | Regression, Cox | 0.968 | Superiority |
|
| 0.447 |
| Superiority |
| Superiority |
| Baseline vs 3 months | t-test, 1 sided | <0.001 | Superiority |
| Baseline vs 3 months | t-test, 1 sided | <0.001 | Superiority |
| Superiority |
| Baseline vs 3 months | t-test, 1 sided | 0.046 | Superiority |
| Baseline vs 3 months | t-test, 1 sided | 0.026 | Superiority |
|
| Fall requiring medical attention |
|
| 1.00 |
| Superiority |
| Fall requiring medical attention | Fisher Exact | 1.00 | Superiority |
| Title | Measurements |
|---|---|
|
| 0.167 |
| Superiority |