Total Hip Arthroplasty
Conditions
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.
Interventions
Infusion
Injection
Injection
Injection, weight-based dosage of 100 mcg - 300 mcg
Injection, 30 mg
Sponsors
Study design
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| Number of Participants Reporting Complications Since Surgery | Post-operative Day 1 Through 3 - Month Follow-up | Complications were collected by telephone interview after surgery. |
| 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. |
| 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). |
| Change in Unipedal Stance Time | Baseline, 3 months | Length of time in seconds a patient could stand on involved leg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| 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 | 54 |
| 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 | 54 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | changed surgical procedure | 1 | 0 | 0 |
| Overall Study | planned post-op anticoagulation | 1 | 0 | 0 |
| Overall Study | postponed surgery | 0 | 0 | 1 |
| Overall Study | preoperative identified neuropathy | 2 | 0 | 0 |
| Overall Study | preoperative opioid consumption | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PAI Ropivacaine | Total | PNB Bupivacaine | PAI Liposomal Bupivacaine |
|---|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 15.3 | 61.0 years STANDARD_DEVIATION 12.9 | 62.1 years STANDARD_DEVIATION 11.5 | 61.7 years STANDARD_DEVIATION 11.7 |
| American Society of Anesthesiologists (ASA) Status III | 13 Participants | 29 Participants | 7 Participants | 9 Participants |
| American Society of Anesthesiologists (ASA) Status I or II | 41 Participants | 130 Participants | 44 Participants | 45 Participants |
| BMI | 30.1 kg/m2 STANDARD_DEVIATION 6 | 30.1 kg/m2 STANDARD_DEVIATION 5.8 | 30.0 kg/m2 STANDARD_DEVIATION 6 | 30.2 kg/m2 STANDARD_DEVIATION 5.4 |
| Duration of surgery | 88.1 minutes STANDARD_DEVIATION 23.2 | 89.2 minutes STANDARD_DEVIATION 25.2 | 91.4 minutes STANDARD_DEVIATION 24 | 88.4 minutes STANDARD_DEVIATION 28.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | 54 participants | 159 participants | 51 participants | 54 participants |
| Sex: Female, Male Female | 27 Participants | 80 Participants | 25 Participants | 28 Participants |
| Sex: Female, Male Male | 27 Participants | 79 Participants | 26 Participants | 26 Participants |
| Type of anesthetic General | 10 Participants | 36 Participants | 13 Participants | 13 Participants |
| Type of anesthetic Spinal | 44 Participants | 123 Participants | 38 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 0 / 51 | 3 / 54 | 1 / 54 |
| serious Total, serious adverse events | 0 / 51 | 0 / 54 | 0 / 54 |
Outcome results
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.
Time frame: Post-Operative Day 1 (0600-1200)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PNB Bupivacaine | Maximum Postoperative Pain Score | 3.0 units on a scale |
| PAI Ropivacaine | Maximum Postoperative Pain Score | 4.0 units on a scale |
| PAI Liposomal Bupivacaine | Maximum Postoperative Pain Score | 3.0 units on a scale |
Total Opioid Consumption During Hospitalization
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
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | Preoperative | 15 Oral morphine equivalent in milligrams |
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | Intraoperative | 10 Oral morphine equivalent in milligrams |
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | Postanesthesia Care Unit (PACU) | 0 Oral morphine equivalent in milligrams |
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | Post Operative Day (POD) 0 post PACU | 7.5 Oral morphine equivalent in milligrams |
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | POD 1 | 22.5 Oral morphine equivalent in milligrams |
| PNB Bupivacaine | Total Opioid Consumption During Hospitalization | POD 2 | 15 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | POD 2 | 15 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | Preoperative | 15 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | Post Operative Day (POD) 0 post PACU | 15 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | POD 1 | 33.8 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | Intraoperative | 10 Oral morphine equivalent in milligrams |
| PAI Ropivacaine | Total Opioid Consumption During Hospitalization | Postanesthesia Care Unit (PACU) | 0 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | Intraoperative | 10 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | Postanesthesia Care Unit (PACU) | 0 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | POD 2 | 11.3 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | Post Operative Day (POD) 0 post PACU | 11.3 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | Preoperative | 15 Oral morphine equivalent in milligrams |
| PAI Liposomal Bupivacaine | Total Opioid Consumption During Hospitalization | POD 1 | 15 Oral morphine equivalent in milligrams |
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).
Time frame: Baseline, 3 months
Population: Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PNB Bupivacaine | Change in Short Form-36 (SF-36) Quality of Life Mental Component | 2.2 units on a scale | Standard Deviation 9.5 |
| PAI Ropivacaine | Change in Short Form-36 (SF-36) Quality of Life Mental Component | 2.6 units on a scale | Standard Deviation 9.4 |
| PAI Liposomal Bupivacaine | Change in Short Form-36 (SF-36) Quality of Life Mental Component | 3.0 units on a scale | Standard Deviation 9.4 |
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).
Time frame: Baseline, 3 months
Population: Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PNB Bupivacaine | Change in Short Form-36 (SF-36) Quality of Life Physical Component | 12.5 units on a scale | Standard Deviation 10.3 |
| PAI Ropivacaine | Change in Short Form-36 (SF-36) Quality of Life Physical Component | 12.6 units on a scale | Standard Deviation 9.1 |
| PAI Liposomal Bupivacaine | Change in Short Form-36 (SF-36) Quality of Life Physical Component | 12.3 units on a scale | Standard Deviation 8.8 |
Change in Unipedal Stance Time
Length of time in seconds a patient could stand on involved leg
Time frame: Baseline, 3 months
Population: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PNB Bupivacaine | Change in Unipedal Stance Time | Baseline | 24.5 seconds |
| PNB Bupivacaine | Change in Unipedal Stance Time | 3 months | 30 seconds |
| PAI Ropivacaine | Change in Unipedal Stance Time | Baseline | 30 seconds |
| PAI Ropivacaine | Change in Unipedal Stance Time | 3 months | 30 seconds |
| PAI Liposomal Bupivacaine | Change in Unipedal Stance Time | Baseline | 30 seconds |
| PAI Liposomal Bupivacaine | Change in Unipedal Stance Time | 3 months | 30 seconds |
Hospital Length of Stay
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PNB Bupivacaine | Hospital Length of Stay | 2 days |
| PAI Ropivacaine | Hospital Length of Stay | 2 days |
| PAI Liposomal Bupivacaine | Hospital Length of Stay | 2 days |
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.
Time frame: 3 month follow up
Population: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PNB Bupivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain at rest | 0 Participants |
| PNB Bupivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain with movement | 0 Participants |
| PAI Ropivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain at rest | 1 Participants |
| PAI Ropivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain with movement | 4 Participants |
| PAI Liposomal Bupivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain at rest | 1 Participants |
| PAI Liposomal Bupivacaine | Number of Participants Reporting a NRS Pain Score Greater Than 3 | Pain with movement | 2 Participants |
Number of Participants Reporting Complications Since Surgery
Complications were collected by telephone interview after surgery.
Time frame: Post-operative Day 1 Through 3 - Month Follow-up
Population: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PNB Bupivacaine | Number of Participants Reporting Complications Since Surgery | Wound infection | 0 Participants |
| PNB Bupivacaine | Number of Participants Reporting Complications Since Surgery | Operative extremity neurologic changes | 1 Participants |
| PNB Bupivacaine | Number of Participants Reporting Complications Since Surgery | Fall requiring medical attention | 1 Participants |
| PAI Ropivacaine | Number of Participants Reporting Complications Since Surgery | Wound infection | 1 Participants |
| PAI Ropivacaine | Number of Participants Reporting Complications Since Surgery | Operative extremity neurologic changes | 1 Participants |
| PAI Ropivacaine | Number of Participants Reporting Complications Since Surgery | Fall requiring medical attention | 2 Participants |
| PAI Liposomal Bupivacaine | Number of Participants Reporting Complications Since Surgery | Operative extremity neurologic changes | 2 Participants |
| PAI Liposomal Bupivacaine | Number of Participants Reporting Complications Since Surgery | Fall requiring medical attention | 1 Participants |
| PAI Liposomal Bupivacaine | Number of Participants Reporting Complications Since Surgery | Wound infection | 1 Participants |
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.
Time frame: 3 month follow-up
Population: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PNB Bupivacaine | Post-Operative Pain Score | Pain at rest | 0 units on a scale |
| PNB Bupivacaine | Post-Operative Pain Score | Pain with movement | 0 units on a scale |
| PAI Ropivacaine | Post-Operative Pain Score | Pain at rest | 0 units on a scale |
| PAI Ropivacaine | Post-Operative Pain Score | Pain with movement | 1 units on a scale |
| PAI Liposomal Bupivacaine | Post-Operative Pain Score | Pain at rest | 0 units on a scale |
| PAI Liposomal Bupivacaine | Post-Operative Pain Score | Pain with movement | 1 units on a scale |