Hip OsteoarthritisPhase 4NCT03801265
Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement
A Phase 4 study testing Lumbar plexus block, Quadratus lumborum type 3 block and Ropivacaine injection in people with Hip Osteoarthritis, run by Sharad Khetarpal at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Lumbar plexus block, Quadratus lumborum type 3 block and Ropivacaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 30 May 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-90 years old
- Primary unilateral total hip arthroplasty
- BMI 20 - 36
- Male and Female
- All races
Who cannot join
- Patient refusal
- ASA class > or = 4
- Pregnancy
- Any condition precluding patient going home with in 24 hours of surgery
- Non-English speaking or inability to participate in the study
- Patients with coagulopathy or on therapeutic anticoagulation
- Chronic Steroid Use
- Narcotic Addiction
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Lumbar plexus block, Quadratus lumborum type 3 block, Ropivacaine injection
- Keywords
- lumbar plexus block, quadratus lumborum block, total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar plexus blockProcedure or surgery
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.
Quadratus lumborum type 3 blockProcedure or surgery
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 injectionDrug
0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Plexus block | Active comparator | 0.5% ropivacaine 100 mg (20 ml) will be injected Receives: Procedure: Lumbar plexus block; Drug: Ropivacaine injection |
| Quadratus Lumborum type 3 block | Experimental | 0.5% ropivacaine 100 mg (20 ml) will be injected Receives: Procedure: Quadratus lumborum type 3 block; Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after surgery
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.
Measured: 6 hours after surgery
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.
Measured: 12 hours after surgery
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.
Measured: 12 hours after surgery
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.
Measured: 24 hours after surgery
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.
Measured: 24 hours after surgery
Secondary outcomes (13)
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.
Measured: 24 hours after surgery
Total Opioid Consumption During 24 Hours After Surgery
Narcotics will be converted to oral morphine equivalents
Measured: 24 hours after surgery
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.
Measured: within 24 hours after surgery
Block Procedure Duration
Duration that the patient underwent the block procedure during surgery in minutes
Measured: during surgery
Patients With Postoperative Quadriceps Weakness
patients who report having post-surgical quadriceps weakness.
Measured: 12 hours after surgery
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)
Measured: 24 hours after surgery
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)
Measured: 24 hours after surgery
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)
Measured: 24 hours after surgery
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)
Measured: 24 hours after surgery
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)
Measured: 24 hours after surgery
Opioid Consumption During 0-6 Hours After Surgery
Narcotics will be converted to oral morphine equivalents
Measured: 6 hours after surgery
Opioid Consumption During 6-12 Hours After Surgery
Narcotics will be converted to oral morphine equivalents
Measured: 6-12 hours after surgery
Opioid Consumption During 12-24 Hours After Surgery
Narcotics will be converted to oral morphine equivalents
Measured: 12-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start19 Mar 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Lumbar plexus block vs Quadratus lumborum type 3 block
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharad Khetarpal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharad Khetarpal, University of Pittsburgh
- Investigators
- Sharad Khetarpal, MD, Principal investigator, Department of Anesthesiology, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801265
- Sponsor's protocol ID
- PRO18120275
- Status last verified
- Jun 2021
- First submitted
- 9 Jan 2019
- Last updated
- 15 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
PubMed 18719448Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available.
PubMed 12552223Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
PubMed 20889937Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
PubMed 27513972La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
PubMed 28036319Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
PubMed 30386022Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11
Polania Gutierrez JJ, Ben-David B, Rest C, Grajales MT, Khetarpal SK. Quadratus lumborum block type 3 versus lumbar plexus block in hip replacement surgery: a randomized, prospective, non-inferiority study. Reg Anesth Pain Med. 2021 Feb;46(2):111-117. doi: 10.1136/rapm-2020-101915. Epub 2020 Nov 11.
PubMed 33177220
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03801265
- Acronym / sponsor ID
- PRO18120275
- Conditions
- Hip Osteoarthritis
- Keywords
- lumbar plexus block, quadratus lumborum block, total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sharad KhetarpalUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Lumbar plexus block vs Quadratus lumborum type 3 block
| Arm | Type | Receives |
|---|---|---|
| Lumbar Plexus block | Active comparator | Procedure: Lumbar plexus block, Drug: Ropivacaine injection0.5% ropivacaine 100 mg (20 ml) will be injected |
| Quadratus Lumborum type 3 block | Experimental | Procedure: Quadratus lumborum type 3 block, Drug: Ropivacaine injection0.5% ropivacaine 100 mg (20 ml) will be injected |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18-90 years old
- Primary unilateral total hip arthroplasty
- BMI 20 - 36
- Male and Female
- All races
Key exclusion criteria (8 listed)
- Patient refusal
- ASA class > or = 4
- Pregnancy
- Any condition precluding patient going home with in 24 hours of surgery
- Non-English speaking or inability to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar plexus blockPatient 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. | Procedure or surgery | Lumbar Plexus block |
| Quadratus lumborum type 3 blockPatient 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. | Procedure or surgery | Quadratus Lumborum type 3 block |
| Ropivacaine injection0.5% ropivacaine 20 ml (100 mg) will be injected for both groups. | Drug | Lumbar Plexus block, Quadratus Lumborum type 3 block |
Primary outcome
Pain at Rest After Surgery
Time frame: 6 hours 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.
Pain With Movement After Surgery
Time frame: 6 hours 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.
Pain at Rest After Surgery
Time frame: 12 hours 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.
Pain With Movement After Surgery
Time frame: 12 hours 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.
Pain at Rest After Surgery
Time frame: 24 hours 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.
Pain With Movement After Surgery
Time frame: 24 hours 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.
13 secondary outcomes
Pain During Physical Therapy
Time frame: 24 hours after surgery
Total Opioid Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Postoperative Time to Accomplish Walking 100 Feet
Time frame: within 24 hours after surgery
Block Procedure Duration
Time frame: during surgery
Patients With Postoperative Quadriceps Weakness
Time frame: 12 hours after surgery
Total Acetaminophen Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Total Celecoxib Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Total Ketorolac Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Total Gabapentin Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Total Oral Ketamine Consumption During 24 Hours After Surgery
Time frame: 24 hours after surgery
Opioid Consumption During 0-6 Hours After Surgery
Time frame: 6 hours after surgery
Opioid Consumption During 6-12 Hours After Surgery
Time frame: 6-12 hours after surgery
Opioid Consumption During 12-24 Hours After Surgery
Time frame: 12-24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18719448Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
- Background: PubMed 12552223Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available.
- Background: PubMed 20889937Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Background: PubMed 27513972Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
- Background: PubMed 28036319La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
- Background: PubMed 30386022Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
- BackgroundBørglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
- BackgroundWinnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11
- Derived from this study: PubMed 33177220Polania Gutierrez JJ, Ben-David B, Rest C, Grajales MT, Khetarpal SK. Quadratus lumborum block type 3 versus lumbar plexus block in hip replacement surgery: a randomized, prospective, non-inferiority study. Reg Anesth Pain Med. 2021 Feb;46(2):111-117. doi: 10.1136/rapm-2020-101915. Epub 2020 Nov 11.
- Individual participant dataSharing planned: No
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Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharad Khetarpal, MD principal investigator
Department of Anesthesiology, University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumbar plexus block, Quadratus lumborum type 3 block and Ropivacaine injection in people with Hip Osteoarthritis, run by Sharad Khetarpal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at Rest After Surgery (time frame: 6 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801265, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.