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Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02242201
Enrollment
165
Registered
2014-09-16
Start date
2014-09-30
Completion date
2016-09-30
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

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

DRUGPNB Bupivacaine

Infusion

DRUGPAI Ropivacaine

Injection

DRUGPAI liposomal bupivacaine

Injection

DRUGEpinephrine

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

DRUGKetorolac

Injection, 30 mg

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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: 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

MeasureTime frameDescription
Maximum Postoperative Pain ScorePost-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

MeasureTime frameDescription
Total Opioid Consumption During HospitalizationPreoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2Measured in daily oral morphine equivalents (OME)

Other

MeasureTime frameDescription
Post-Operative Pain Score3 month follow-upPain 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 ComponentBaseline, 3 monthsScores 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 StayPost-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 SurgeryPost-operative Day 1 Through 3 - Month Follow-upComplications were collected by telephone interview after surgery.
Number of Participants Reporting a NRS Pain Score Greater Than 33 month follow upPain 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 ComponentBaseline, 3 monthsScores 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 TimeBaseline, 3 monthsLength of time in seconds a patient could stand on involved leg

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total159

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studychanged surgical procedure100
Overall Studyplanned post-op anticoagulation100
Overall Studypostponed surgery001
Overall Studypreoperative identified neuropathy200
Overall Studypreoperative opioid consumption010

Baseline characteristics

CharacteristicPAI RopivacaineTotalPNB BupivacainePAI Liposomal Bupivacaine
Age, Continuous59.4 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 Participants29 Participants7 Participants9 Participants
American Society of Anesthesiologists (ASA) Status
I or II
41 Participants130 Participants44 Participants45 Participants
BMI30.1 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 surgery88.1 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 Collected0 Participants
Region of Enrollment
United States
54 participants159 participants51 participants54 participants
Sex: Female, Male
Female
27 Participants80 Participants25 Participants28 Participants
Sex: Female, Male
Male
27 Participants79 Participants26 Participants26 Participants
Type of anesthetic
General
10 Participants36 Participants13 Participants13 Participants
Type of anesthetic
Spinal
44 Participants123 Participants38 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 510 / 540 / 54
other
Total, other adverse events
0 / 513 / 541 / 54
serious
Total, serious adverse events
0 / 510 / 540 / 54

Outcome results

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.

Time frame: Post-Operative Day 1 (0600-1200)

ArmMeasureValue (MEDIAN)
PNB BupivacaineMaximum Postoperative Pain Score3.0 units on a scale
PAI RopivacaineMaximum Postoperative Pain Score4.0 units on a scale
PAI Liposomal BupivacaineMaximum Postoperative Pain Score3.0 units on a scale
p-value: 0.033Wilcoxon (Mann-Whitney)
p-value: 0.662Wilcoxon (Mann-Whitney)
p-value: 0.103Wilcoxon (Mann-Whitney)
Secondary

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).

ArmMeasureGroupValue (MEDIAN)
PNB BupivacaineTotal Opioid Consumption During HospitalizationPreoperative15 Oral morphine equivalent in milligrams
PNB BupivacaineTotal Opioid Consumption During HospitalizationIntraoperative10 Oral morphine equivalent in milligrams
PNB BupivacaineTotal Opioid Consumption During HospitalizationPostanesthesia Care Unit (PACU)0 Oral morphine equivalent in milligrams
PNB BupivacaineTotal Opioid Consumption During HospitalizationPost Operative Day (POD) 0 post PACU7.5 Oral morphine equivalent in milligrams
PNB BupivacaineTotal Opioid Consumption During HospitalizationPOD 122.5 Oral morphine equivalent in milligrams
PNB BupivacaineTotal Opioid Consumption During HospitalizationPOD 215 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationPOD 215 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationPreoperative15 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationPost Operative Day (POD) 0 post PACU15 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationPOD 133.8 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationIntraoperative10 Oral morphine equivalent in milligrams
PAI RopivacaineTotal Opioid Consumption During HospitalizationPostanesthesia Care Unit (PACU)0 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationIntraoperative10 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationPostanesthesia Care Unit (PACU)0 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationPOD 211.3 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationPost Operative Day (POD) 0 post PACU11.3 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationPreoperative15 Oral morphine equivalent in milligrams
PAI Liposomal BupivacaineTotal Opioid Consumption During HospitalizationPOD 115 Oral morphine equivalent in milligrams
Comparison: Preoperativep-value: 0.948Wilcoxon (Mann-Whitney)
Comparison: Preoperativep-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: Preoperativep-value: 0.802Wilcoxon (Mann-Whitney)
Comparison: Intraoperativep-value: 0.179Wilcoxon (Mann-Whitney)
Comparison: Intraoperativep-value: 0.837Wilcoxon (Mann-Whitney)
Comparison: Intraoperativep-value: 0.142Wilcoxon (Mann-Whitney)
Comparison: PACUp-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: PACUp-value: 0.516Wilcoxon (Mann-Whitney)
Comparison: PACUp-value: 0.052Wilcoxon (Mann-Whitney)
Comparison: POD 0 post PACUp-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: POD 0 post PACUp-value: 0.744Wilcoxon (Mann-Whitney)
Comparison: POD 0 post PACUp-value: 0.501Wilcoxon (Mann-Whitney)
Comparison: POD 1p-value: 0.358Wilcoxon (Mann-Whitney)
Comparison: POD 1p-value: 0.536Wilcoxon (Mann-Whitney)
Comparison: POD 1p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: POD 2p-value: 0.313Wilcoxon (Mann-Whitney)
Comparison: POD 2p-value: 0.893Wilcoxon (Mann-Whitney)
Comparison: POD 2p-value: 0.232Wilcoxon (Mann-Whitney)
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).

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.

ArmMeasureValue (MEAN)Dispersion
PNB BupivacaineChange in Short Form-36 (SF-36) Quality of Life Mental Component2.2 units on a scaleStandard Deviation 9.5
PAI RopivacaineChange in Short Form-36 (SF-36) Quality of Life Mental Component2.6 units on a scaleStandard Deviation 9.4
PAI Liposomal BupivacaineChange in Short Form-36 (SF-36) Quality of Life Mental Component3.0 units on a scaleStandard Deviation 9.4
Comparison: Baseline vs 3 monthsp-value: 0.026t-test, 1 sided
p-value: 0.898ANOVA
Comparison: Baseline vs 3 monthsp-value: 0.112t-test, 1 sided
Comparison: Baseline vs 3 monthsp-value: 0.046t-test, 1 sided
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).

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.

ArmMeasureValue (MEAN)Dispersion
PNB BupivacaineChange in Short Form-36 (SF-36) Quality of Life Physical Component12.5 units on a scaleStandard Deviation 10.3
PAI RopivacaineChange in Short Form-36 (SF-36) Quality of Life Physical Component12.6 units on a scaleStandard Deviation 9.1
PAI Liposomal BupivacaineChange in Short Form-36 (SF-36) Quality of Life Physical Component12.3 units on a scaleStandard Deviation 8.8
p-value: 0.986ANOVA
Comparison: Baseline vs 3 monthsp-value: <0.001t-test, 1 sided
Comparison: Baseline vs 3 monthsp-value: <0.001t-test, 1 sided
Comparison: Baseline vs 3 monthsp-value: <0.001t-test, 1 sided
Other Pre-specified

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.

ArmMeasureGroupValue (MEDIAN)
PNB BupivacaineChange in Unipedal Stance TimeBaseline24.5 seconds
PNB BupivacaineChange in Unipedal Stance Time3 months30 seconds
PAI RopivacaineChange in Unipedal Stance TimeBaseline30 seconds
PAI RopivacaineChange in Unipedal Stance Time3 months30 seconds
PAI Liposomal BupivacaineChange in Unipedal Stance TimeBaseline30 seconds
PAI Liposomal BupivacaineChange in Unipedal Stance Time3 months30 seconds
Comparison: Baselinep-value: 0.251Regression, Cox
Comparison: 3 month follow-upp-value: 0.3Regression, Cox
Comparison: Baseline vs 3 monthsp-value: 0.113Regression, Cox
Comparison: Baseline vs 3 monthsp-value: 0.147Regression, Cox
Comparison: Baseline vs 3 monthsp-value: 0.216Regression, Cox
Comparison: Baseline vs 3 monthsp-value: 0.968Regression, Cox
Other Pre-specified

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)

ArmMeasureValue (MEDIAN)
PNB BupivacaineHospital Length of Stay2 days
PAI RopivacaineHospital Length of Stay2 days
PAI Liposomal BupivacaineHospital Length of Stay2 days
p-value: 0.772Kruskal-Wallis
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PNB BupivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain at rest0 Participants
PNB BupivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain with movement0 Participants
PAI RopivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain at rest1 Participants
PAI RopivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain with movement4 Participants
PAI Liposomal BupivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain at rest1 Participants
PAI Liposomal BupivacaineNumber of Participants Reporting a NRS Pain Score Greater Than 3Pain with movement2 Participants
Comparison: Pain at restp-value: 1Fisher Exact
Comparison: Pain with movementp-value: 0.167Fisher Exact
Other Pre-specified

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PNB BupivacaineNumber of Participants Reporting Complications Since SurgeryWound infection0 Participants
PNB BupivacaineNumber of Participants Reporting Complications Since SurgeryOperative extremity neurologic changes1 Participants
PNB BupivacaineNumber of Participants Reporting Complications Since SurgeryFall requiring medical attention1 Participants
PAI RopivacaineNumber of Participants Reporting Complications Since SurgeryWound infection1 Participants
PAI RopivacaineNumber of Participants Reporting Complications Since SurgeryOperative extremity neurologic changes1 Participants
PAI RopivacaineNumber of Participants Reporting Complications Since SurgeryFall requiring medical attention2 Participants
PAI Liposomal BupivacaineNumber of Participants Reporting Complications Since SurgeryOperative extremity neurologic changes2 Participants
PAI Liposomal BupivacaineNumber of Participants Reporting Complications Since SurgeryFall requiring medical attention1 Participants
PAI Liposomal BupivacaineNumber of Participants Reporting Complications Since SurgeryWound infection1 Participants
Comparison: Operative extremity neurologic changesp-value: 0.843Fisher Exact
Comparison: Wound infectionp-value: 1Fisher Exact
Comparison: Fall requiring medical attentionp-value: 1Fisher Exact
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.

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.

ArmMeasureGroupValue (MEDIAN)
PNB BupivacainePost-Operative Pain ScorePain at rest0 units on a scale
PNB BupivacainePost-Operative Pain ScorePain with movement0 units on a scale
PAI RopivacainePost-Operative Pain ScorePain at rest0 units on a scale
PAI RopivacainePost-Operative Pain ScorePain with movement1 units on a scale
PAI Liposomal BupivacainePost-Operative Pain ScorePain at rest0 units on a scale
PAI Liposomal BupivacainePost-Operative Pain ScorePain with movement1 units on a scale
Comparison: Pain at restp-value: 0.776Kruskal-Wallis
Comparison: Pain with movementp-value: 0.447Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026