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Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement

A Prospective, Randomized, Double-blinded, Active-comparator, Non-inferiority Study to Observe Relative Efficacy of Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Class Lumbar Plexus Block in Managing Post-operative Pain Following Total Hip Replacement Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03801265
Enrollment
46
Registered
2019-01-11
Start date
2019-03-19
Completion date
2020-05-30
Last updated
2021-07-15

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

Conditions

Hip Osteoarthritis

Keywords

lumbar plexus block, quadratus lumborum block, total hip arthroplasty

Brief summary

The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia technique to provide postoperative pain management after primary hip replacement surgery at UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with potentially serious side effects, including nerve injury, major bleeding, retroperitoneal hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can also lead to motor blockade, interfering with early ambulation. There are several case reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief after total hip replacement surgery, and this QL3 block is performed routinely at this institution. The benefits to inter-fascial administration of local anesthetic include the avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration associated with the direct interaction between the nerve and the nerve block needle. The purpose of this study is to show that QL3 block is non-inferior to the standard-of-care lumbar plexus block and should be used more regularly in hip replacement surgery. The study will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority, active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block for post-operative pain management in subjects undergoing primary, unilateral hip replacement surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and physical therapy response. Primary outcome measures include pain at rest and with movement at 6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by a physical therapist.

Detailed description

Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative area on their day of surgery. The anesthesiology investigator will speak with the patient about the study behind a closed drape and the patient will have adequate time to consider the consent and ask questions regarding risk factors associated with each type of block. Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups. Once assigned the treatment allocation, only the clinician administering the block will be unblinded to the randomization outcome. If randomized to the LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. For both treatment groups, the local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary outcome measures. These include pain at rest and with movement at 6, 12 and 24 hours after surgery, time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by physical therapist. This information will be captured from the patient's electronic medical record. Minor changes were made to the outcome measures after the original approval of this submission. This was only to clarify the specific measures from the more general descriptions in the original.

Interventions

Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.

PROCEDUREQuadratus lumborum type 3 block

Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.

DRUGRopivacaine injection

0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Sponsors

Sharad Khetarpal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The person who perform the block will be unblinded. The participants and the outcomes assessor will be blinded to the treatment allocations.

Intervention model description

Lumbar plexus block vs Quadratus lumborum type 3 block

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Patients 18-90 years old 2. Primary unilateral total hip arthroplasty 3. BMI 20 - 36 4. Male and Female 5. All races

Exclusion criteria

1. Patient refusal 2. ASA class \> or = 4 3. Pregnancy 4. Any condition precluding patient going home with in 24 hours of surgery 5. Non-English speaking or inability to participate in the study 6. Patients with coagulopathy or on therapeutic anticoagulation 7. Chronic Steroid Use 8. Narcotic Addiction

Design outcomes

Primary

MeasureTime frameDescription
Pain at Rest After Surgery6 hours after surgeryVisual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.
Pain With Movement After Surgery6 hours after surgeryVisual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Secondary

MeasureTime frameDescription
Postoperative Time to Accomplish Walking 100 Feetwithin 24 hours after surgeryThis measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.
Block Procedure Durationduring surgeryDuration that the patient underwent the block procedure during surgery in minutes
Patients With Postoperative Quadriceps Weakness12 hours after surgerypatients who report having post-surgical quadriceps weakness.
Total Acetaminophen Consumption During 24 Hours After Surgery24 hours after surgeryPatient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)
Total Celecoxib Consumption During 24 Hours After Surgery24 hours after surgeryPatient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)
Pain During Physical Therapy24 hours after surgeryVisual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.
Total Gabapentin Consumption During 24 Hours After Surgery24 hours after surgeryPatient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)
Total Oral Ketamine Consumption During 24 Hours After Surgery24 hours after surgeryPatient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)
Opioid Consumption During 0-6 Hours After Surgery6 hours after surgeryNarcotics will be converted to oral morphine equivalents
Opioid Consumption During 6-12 Hours After Surgery6-12 hours after surgeryNarcotics will be converted to oral morphine equivalents
Opioid Consumption During 12-24 Hours After Surgery12-24 hours after surgeryNarcotics will be converted to oral morphine equivalents
Total Ketorolac Consumption During 24 Hours After Surgery24 hours after surgeryPatient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)
Total Opioid Consumption During 24 Hours After Surgery24 hours after surgeryNarcotics will be converted to oral morphine equivalents

Countries

United States

Participant flow

Participants by arm

ArmCount
Lumbar Plexus Block
0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
23
Quadratus Lumborum Type 3 Block
0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
23
Total46

Baseline characteristics

CharacteristicLumbar Plexus BlockQuadratus Lumborum Type 3 BlockTotal
Age, Continuous65.7 years
STANDARD_DEVIATION 9.8
68.6 years
STANDARD_DEVIATION 11.8
67.1 years
STANDARD_DEVIATION 10.7
Race/Ethnicity, Customized
African American
7 Participants4 Participants11 Participants
Race/Ethnicity, Customized
Caucasian
16 Participants19 Participants35 Participants
Region of Enrollment
United States
23 Participants23 Participants46 Participants
Sex: Female, Male
Female
11 Participants13 Participants24 Participants
Sex: Female, Male
Male
12 Participants10 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 23
other
Total, other adverse events
0 / 230 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame: 6 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPain at Rest After Surgery3.4 score on a scaleStandard Deviation 3
Quadratus Lumborum Type 3 BlockPain at Rest After Surgery3.6 score on a scaleStandard Deviation 1.9
p-value: 0.77Wilcoxon (Mann-Whitney)
Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame: 24 hours after surgery

ArmMeasureValue (MEDIAN)Dispersion
Lumbar Plexus BlockPain at Rest After Surgery2.8 score on a scaleStandard Deviation 2.6
Quadratus Lumborum Type 3 BlockPain at Rest After Surgery1.8 score on a scaleStandard Deviation 1.5
p-value: 0.122Wilcoxon (Mann-Whitney)
Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame: 12 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPain at Rest After Surgery3.0 score on a scaleStandard Deviation 2.9
Quadratus Lumborum Type 3 BlockPain at Rest After Surgery2.8 score on a scaleStandard Deviation 2
p-value: 0.859Wilcoxon (Mann-Whitney)
Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame: 24 hours after surgery

ArmMeasureValue (MEDIAN)Dispersion
Lumbar Plexus BlockPain With Movement After Surgery4.9 score on a scaleStandard Deviation 2.8
Quadratus Lumborum Type 3 BlockPain With Movement After Surgery4.3 score on a scaleStandard Deviation 1.8
p-value: 0.379Wilcoxon (Mann-Whitney)
Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame: 6 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPain With Movement After Surgery4.9 score on a scaleStandard Deviation 3.2
Quadratus Lumborum Type 3 BlockPain With Movement After Surgery4.7 score on a scaleStandard Deviation 2
p-value: 0.826Wilcoxon (Mann-Whitney)
Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame: 12 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPain With Movement After Surgery4.5 score on a scaleStandard Deviation 2.8
Quadratus Lumborum Type 3 BlockPain With Movement After Surgery4.6 score on a scaleStandard Deviation 2.1
p-value: 0.904Wilcoxon (Mann-Whitney)
Secondary

Block Procedure Duration

Duration that the patient underwent the block procedure during surgery in minutes

Time frame: during surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockBlock Procedure Duration11.7 minutesStandard Deviation 6.1
Quadratus Lumborum Type 3 BlockBlock Procedure Duration6.6 minutesStandard Deviation 4.7
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary

Opioid Consumption During 0-6 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame: 6 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockOpioid Consumption During 0-6 Hours After Surgery3.4 mg oral morphine equivalentsStandard Deviation 3.2
Quadratus Lumborum Type 3 BlockOpioid Consumption During 0-6 Hours After Surgery6.3 mg oral morphine equivalentsStandard Deviation 4.5
p-value: 0.015Wilcoxon (Mann-Whitney)
Secondary

Opioid Consumption During 12-24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame: 12-24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockOpioid Consumption During 12-24 Hours After Surgery5.7 mg oral morphine equivalentsStandard Deviation 4.6
Quadratus Lumborum Type 3 BlockOpioid Consumption During 12-24 Hours After Surgery5.0 mg oral morphine equivalentsStandard Deviation 5.9
p-value: 0.672Wilcoxon (Mann-Whitney)
Secondary

Opioid Consumption During 6-12 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame: 6-12 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockOpioid Consumption During 6-12 Hours After Surgery5.0 mg oral morphine equivalentsStandard Deviation 4.2
Quadratus Lumborum Type 3 BlockOpioid Consumption During 6-12 Hours After Surgery3.4 mg oral morphine equivalentsStandard Deviation 4
p-value: 0.203Wilcoxon (Mann-Whitney)
Secondary

Pain During Physical Therapy

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPain During Physical Therapy4.3 score on a scaleStandard Deviation 2.5
Quadratus Lumborum Type 3 BlockPain During Physical Therapy4.2 score on a scaleStandard Deviation 1.3
p-value: 0.881Wilcoxon (Mann-Whitney)
Secondary

Patients With Postoperative Quadriceps Weakness

patients who report having post-surgical quadriceps weakness.

Time frame: 12 hours after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lumbar Plexus BlockPatients With Postoperative Quadriceps Weakness15 Participants
Quadratus Lumborum Type 3 BlockPatients With Postoperative Quadriceps Weakness6 Participants
p-value: 0.007Chi-squared
Secondary

Postoperative Time to Accomplish Walking 100 Feet

This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.

Time frame: within 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockPostoperative Time to Accomplish Walking 100 Feet1449.1 minutesStandard Deviation 760.7
Quadratus Lumborum Type 3 BlockPostoperative Time to Accomplish Walking 100 Feet1358.3 minutesStandard Deviation 715.5
p-value: 0.678Wilcoxon (Mann-Whitney)
Secondary

Total Acetaminophen Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Acetaminophen Consumption During 24 Hours After Surgery2782.6 milligrams (mg)Standard Deviation 902.3
Quadratus Lumborum Type 3 BlockTotal Acetaminophen Consumption During 24 Hours After Surgery3087.0 milligrams (mg)Standard Deviation 949.3
p-value: 0.271Wilcoxon (Mann-Whitney)
Secondary

Total Celecoxib Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Celecoxib Consumption During 24 Hours After Surgery191.3 milligrams (mg)Standard Deviation 185.7
Quadratus Lumborum Type 3 BlockTotal Celecoxib Consumption During 24 Hours After Surgery178.3 milligrams (mg)Standard Deviation 180.8
p-value: 0.81Wilcoxon (Mann-Whitney)
Secondary

Total Gabapentin Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Gabapentin Consumption During 24 Hours After Surgery382.6 milligrams (mg)Standard Deviation 238.7
Quadratus Lumborum Type 3 BlockTotal Gabapentin Consumption During 24 Hours After Surgery395.7 milligrams (mg)Standard Deviation 481.9
p-value: 0.908Wilcoxon (Mann-Whitney)
Secondary

Total Ketorolac Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Ketorolac Consumption During 24 Hours After Surgery9.8 milligrams (mg)Standard Deviation 17.3
Quadratus Lumborum Type 3 BlockTotal Ketorolac Consumption During 24 Hours After Surgery12.4 milligrams (mg)Standard Deviation 24.2
p-value: 0.676Wilcoxon (Mann-Whitney)
Secondary

Total Opioid Consumption During 24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Opioid Consumption During 24 Hours After Surgery14.0 mg oral morphine equivalentsStandard Deviation 9.3
Quadratus Lumborum Type 3 BlockTotal Opioid Consumption During 24 Hours After Surgery14.7 mg oral morphine equivalentsStandard Deviation 10.7
p-value: 0.818Wilcoxon (Mann-Whitney)
Secondary

Total Oral Ketamine Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)

Time frame: 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
Lumbar Plexus BlockTotal Oral Ketamine Consumption During 24 Hours After Surgery7.4 milligrams (mg)Standard Deviation 12.5
Quadratus Lumborum Type 3 BlockTotal Oral Ketamine Consumption During 24 Hours After Surgery13.5 milligrams (mg)Standard Deviation 22.9
p-value: 0.27Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026