Total Hip ArthroplastyPhase 2/3NCT03408483
Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
A Phase 2/3 study testing Quadratus Lumborum Block (QLB) in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Quadratus Lumborum Block (QLB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 22 Aug 2020
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total hip arthroplasty
- Adults 18 years of age and older
- Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
Who cannot join
- Patients with ASA physical status classification other than I, II, or III
- Patients with allergies/intolerances to local anesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
- Patients with coexisting coagulopathy
- Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines or if spinal anesthesia would be contraindicated according to guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. At our institution, post-operative analgesia in these patients is primarily provided through parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and implemented for various surgical procedures including caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a precedent regarding the efficacy of the QLB for THA in providing superior analgesia and decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores, and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing THA. The results of this study have the potential to change standard of care for patients undergoing THA.
Read the detailed description
Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliac blocks have been employed to provide analgesia for hip surgeries with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-operative analgesia, but the complexity of the block is high, and complications including epidural anesthesia are not infrequent. The quadratus lumborum block is an abdominal truncal block in which local anesthetic is deposited into the thoracolumbar fascia or the quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 - L1 sensory dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain abdominal and pelvic surgeries, but its use in total hip arthroplasty is limited to case reports.
The block is accomplished by identifying the quadratus lumborum muscle, which originates from iliac crest and iliolumbar ligament, and inserted on transverse processes of upper four lumbar vertebrae and posterior border of the 12th rib. Local anesthetic is then deposited at the anterior, posterior or middle thoracolumbar fascia, or intramuscularly, depending on the technique used. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a "posterior TAP" block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA. The QLB block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions of lumbar plexus.
This study has been designed to investigate the efficacy of the quadratus lumborum block as a primary method of providing post-operative analgesia in patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty. In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival \& discharge12, 24 \& 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Quadratus Lumborum Block (QLB), Standard of Care
- Keywords
- Quadratus Lumborum Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum Block (QLB)Drug
Also called bolus, bupivacaine, epinephrine, aliquots
Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic.
Standard of CareDrug
Also called parenteral opioid, oral opioid
This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum block (QLB) | Experimental | * Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia. Receives: Drug: Quadratus Lumborum Block (QLB) |
| Standard of Care | Active comparator | * Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:
Rating - Pain Level
0 - No Pain
1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)
4-6 - Moderate Pain (interferes significantly with ADLs)
7-10 - Severe Pain (disabling; unable to perform ADLs)
*ADL=Activities of Daily Living
Measured: Assessed between immediately postoperatively to 12 hours postoperatively
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:
Rating - Pain Level
0 - No Pain
1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)
4-6 - Moderate Pain (interferes significantly with ADLs)
7-10 - Severe Pain (disabling; unable to perform ADLs)
*ADL=Activities of Daily Living
Measured: Assessed between immediately postoperatively to 24 hours postoperatively
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:
Rating - Pain Level
0 - No Pain
1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)
4-6 - Moderate Pain (interferes significantly with ADLs)
7-10 - Severe Pain (disabling; unable to perform ADLs)
*ADL=Activities of Daily Living
Measured: Assessed between immediately postoperatively to 48 hours postoperatively
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Measured: from 24 hours to 48 hours postoperatively
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Measured: immediately postoperatively to 24 hours postoperatively
Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated
Measured: immediately postoperatively to 48 hours postoperatively
Pain Scores Using Visual Analog Scale (VAS) Scores
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:
Rating - Pain Level
0 - No Pain
1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)
4-6 - Moderate Pain (interferes significantly with ADLs)
7-10 - Severe Pain (disabling; unable to perform ADLs)
*ADL=Activities of Daily Living
Measured: Immediately postoperatively to 12 hours postoperatively
Secondary outcomes (4)
Patient Satisfaction
Patient Satisfaction Score:
Determined by patient interview conducted at the 24 hour Time Frame.
The interview follows a script requesting current pain level based on a scale of 1-10:
1 = very not satisfied 10 = very satisfied
Patient satisfaction is subjective.
Measured: 24 hours
Hours to Hospital Discharge
From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.
Measured: Maximum 96 Hours
Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet
Measured: 48 hours
Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Apr 2018
- Primary completion10 May 2019
- Study completion22 Aug 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 (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival \& dischage,12, 24 \& 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Promil Kukreja, University of Alabama at Birmingham
- Investigators
- Promil Kukreja, MD, PhD, Principal investigator, UAB Department of Anesthesiology, Critical Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408483
- Sponsor's protocol ID
- 300000836
- Status last verified
- May 2021
- First submitted
- 19 Dec 2017
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kukreja P, MacBeth L, Sturdivant A, Morgan CJ, Ghanem E, Kalagara H, Chan VWS. Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100804. doi: 10.1136/rapm-2019-100804. Online ahead of print.
PubMed 31653800
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03408483
- Acronym / sponsor ID
- 300000836
- Conditions
- Total Hip Arthroplasty
- Keywords
- Quadratus Lumborum Block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 22 Aug 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. At our institution, post-operative analgesia in these patients is primarily provided through parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and implemented for various surgical procedures including caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a precedent regarding the efficacy of the QLB for THA in providing superior analgesia and decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores, and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing THA. The results of this study have the potential to change standard of care for patients undergoing THA.
Detailed description
Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliac blocks have been employed to provide analgesia for hip surgeries with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-operative analgesia, but the complexity of the block is high, and complications including epidural anesthesia are not infrequent. The quadratus lumborum block is an abdominal truncal block in which local anesthetic is deposited into the thoracolumbar fascia or the quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 - L1 sensory dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain abdominal and pelvic surgeries, but its use in total hip arthroplasty is limited to case reports.
The block is accomplished by identifying the quadratus lumborum muscle, which originates from iliac crest and iliolumbar ligament, and inserted on transverse processes of upper four lumbar vertebrae and posterior border of the 12th rib. Local anesthetic is then deposited at the anterior, posterior or middle thoracolumbar fascia, or intramuscularly, depending on the technique used. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a "posterior TAP" block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA. The QLB block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions of lumbar plexus.
This study has been designed to investigate the efficacy of the quadratus lumborum block as a primary method of providing post-operative analgesia in patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty. In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival \& discharge12, 24 \& 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival \& dischage,12, 24 \& 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum block (QLB) | Experimental | Drug: Quadratus Lumborum Block (QLB)* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort. * Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots. * After QLB is placed, patients will have THA under spinal anesthesia. |
| Standard of Care | Active comparator | Drug: Standard of Care* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort. * Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing total hip arthroplasty
- Adults 18 years of age and older
- Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
Key exclusion criteria (5 listed)
- Patients with ASA physical status classification other than I, II, or III
- Patients with allergies/intolerances to local anesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
- Patients with coexisting coagulopathy
- Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines or if spinal anesthesia would be contraindicated according to guidelines
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 |
|---|---|---|
| Quadratus Lumborum Block (QLB)Also: bolus, bupivacaine, epinephrine, aliquotsUnder ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic. | Drug | quadratus lumborum block (QLB) |
| Standard of CareAlso: parenteral opioid, oral opioidThis is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication. | Drug | Standard of Care |
Primary outcome
Pain Scores Using Visual Analog Scale (VAS) Scores
Time frame: Assessed between immediately postoperatively to 12 hours postoperatively
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) *ADL=Activities of Daily Living
Pain Scores Using Visual Analog Scale (VAS) Scores
Time frame: Assessed between immediately postoperatively to 24 hours postoperatively
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) *ADL=Activities of Daily Living
Pain Scores Using Visual Analog Scale (VAS) Scores
Time frame: Assessed between immediately postoperatively to 48 hours postoperatively
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) *ADL=Activities of Daily Living
Opioid Consumption (Oral Morphine Equivalents)
Time frame: from 24 hours to 48 hours postoperatively
Total oral morphine equivalent consumption calculated
Opioid Consumption (Oral Morphine Equivalents)
Time frame: immediately postoperatively to 24 hours postoperatively
Total oral morphine equivalent consumption calculated
Opioid Consumption (Oral Morphine Equivalents)
Time frame: immediately postoperatively to 48 hours postoperatively
Total oral morphine equivalent consumption calculated
Pain Scores Using Visual Analog Scale (VAS) Scores
Time frame: Immediately postoperatively to 12 hours postoperatively
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) *ADL=Activities of Daily Living
4 secondary outcomes
Patient Satisfaction
Time frame: 24 hours
Hours to Hospital Discharge
Time frame: Maximum 96 Hours
Distance Ambulated
Time frame: 48 hours
Distance Ambulated
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31653800Kukreja P, MacBeth L, Sturdivant A, Morgan CJ, Ghanem E, Kalagara H, Chan VWS. Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100804. doi: 10.1136/rapm-2019-100804. Online ahead of print.
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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.
Promil Kukreja, MD, PhD principal investigator
UAB Department of Anesthesiology, Critical Care Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quadratus Lumborum Block (QLB) in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham 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 3 inclusion and 5 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 9 Jun 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Sep 2020). 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 Scores Using Visual Analog Scale (VAS) Scores (time frame: Assessed between immediately postoperatively to 12 hours postoperatively). The study lists 7 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 NCT03408483, which also lists 1 linked publication.
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 9 Jun 2021.