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There is Controversy about what is more critical volume or concentration to achieve an optimum analgesic treatment with quadratus lumborum block. From the experiences of the authors, the regular dose of 20 ml of Bupivacaine at 0.375% concentration could not be enough in some cases to produce an optimum analgesic treatment, especially in hip arthroplasties. What is proposed in this study is to evaluate whether the volume injected in the quadratus lumborum block is more important than the concentration of the local anesthetic in terms of control of pain during the next 24 hours after surgery and opioid consumption.
The Quadratus Lumborum Block (QLB) was originally described by Blanco in 2007 as a posterior variation of the Transversus Abdominis Plane block. It is now, however, recognized as a unique, alternative, and separate interfascial plane block. The QLB has been studied and compared with other types of blocks and it may offer several advantages such as simplicity, safety, and avoidance of hypotension. Additionally, dermatomal coverage may be greater than for other types of blocks. In cadaveric studies the paravertebral spread of dye was found from T7-L5 , although an vivo study in healthy volunteers showed the paravertebral spread of the contrast solution only between T10-L1 at 1 hour after the block. It is noted that while these anatomical studies invariably show the spread of contrast or dye extending to the paravertebral space that spread may be limited in degree. Thus follows a point of significant controversy as to whether the paravertebral space is in fact the block's primary site of action or whether it acts primarily on nerves, radicular and sympathetic, situated in the thoracolumbar fascia. Questions of mechanism and site of action notwithstanding, the safety and clinical efficacy of this block has been clearly demonstrated in multiple types of surgeries including abdominal laparoscopic , open laparotomy , urologic , and general surgery with analgesia lasting roughly 24 hours, decreased consumption of opioids, decreased time to ambulation, and decreased hospital length of stay. In recent studies, QL block employment was shown to produce a significant reduction in length of stay during hip surgery as well as similar analgesia to Lumbar Plexus blockade.
The quadratus lumborum block has since 2016 become standard of care for abdominal and hip surgeries at our institution, replacing paravertebral and lumbar plexus blocks respectively, and as part of a broader multimodal analgesia institutional ERAS (Enhanced Recovery After Surgery) protocol. Coincident with its implementation we have seen significant reductions in opiate and PCA use as well as hospital length of stay. Similar results have been reported by other institutions.
Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. There remain many unanswered questions regarding this block and its subtypes. It is, for example, unknown if one technique would be better than another for different types of surgery. Likewise little is known of the relative importance of local anesthetic concentration and injectate volume - the principal question addressed by this proposed study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Volume group | Active Comparator | 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each subject received 20mL Bupivacaine 0.375%. |
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| High Volume group | Experimental | 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each subject was given 20mL Bupivacaine 0.375% diluted with 20mL normal saline to total 40mL (concentration decreased by half - 0.1875%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Bupivacaine 0.375% 20 mL | Drug | 20 mL 0.375% Bupivacaine |
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| Measure | Description | Time Frame |
|---|---|---|
| Consumption of Opioids During the First 24 Hours After Surgery. | Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent | 24 hours |
| Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10) | 3-hours |
| Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10) | 6-hours |
| Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10) | 12-hours |
| Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10) | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 100ft Ambulation After Surgery | Time to ambulation after surgery (ability to walk 100 feet). | Post-operative 12-32 hours |
| Time to Consumption of the First Opioid After Surgery. | Time to consumption of the first opioid after surgery. |
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Inclusion Criteria:
Patients 18-80 years old Patients undergoing total hip arthroplasty BMI 19-45, >50 kg Male and Female All races American Society of Anesthesiologists physical status classification I, II, III Spinal Anesthesia Provided
Exclusion Criteria:
Pregnancy Non english speaking or inability to participate in the study Patients with coagulopathy or With INR >1.5 the day of the surgery. pharmacologic coagulopathy: patients on xarelto, plavix, or any kind of "Blood Thinners" Chronic steroid use: patients with consumption of steroid for more than 3 months.
Chronic pain: pain for more than 3 months Chronic opiate use : consumption of opioids for more than 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Uskova, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC shadyside hospital |
There is no plan to share individual participant data
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Volume Group | 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml Drug: Bupivacaine 0.375%: Each block of 0.375% Bupivacaine x 20 ml |
| FG001 | High Volume Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2020 |
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The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
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An envelope will contain the randomized concentration and volume of ropivacaine to be administered to the patient. Once the anesthesiologist knows which volume he is going to administer, he will reseal the envelope and return it to the research team. This process will allow only the anesthesiologist performing the block to have knowledge of the volume he is administering, keeping both the patients and outcome assessor of the research team blinded.
The anesthesiologist will fill the syringe with the appropriate volume of medication. Immediately after, he will cover the numbers on the syringe with a piece of opaque tape, preventing any others from visualizing the volume to be administered.
| Drug: Bupivacaine 0.375% diluted to 0.1875% | Drug | Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL) |
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| 24 hours |
| Time to Hospital Discharge | Time to hospital discharge following surgery, measured in minutes | Post-operative day 1 to post-operative day 5 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL Drug: Bupivacaine 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL (total 40mL) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Volume Group | 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml Drug: Bupivacaine 0.375%: Each block of 0.375% Bupivacaine x 20 mL |
| BG001 | High Volume Group | 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL Drug: Bupivacaine 0.375% 20 mL: Each block of 0.375% Bupivacaine x 20 mL diluted with 20mL of Normal Saline Solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Consumption of Opioids During the First 24 Hours After Surgery. | Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent | Posted | Mean | Standard Deviation | mg morphine equivalents per 24 hours | 24 hours |
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| Primary | Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10) | Posted | Mean | Standard Deviation | score on a scale | 3-hours |
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| Primary | Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10) | Posted | Mean | Standard Deviation | score on a scale | 6-hours |
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| Primary | Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10) | Posted | Mean | Standard Deviation | score on a scale | 12-hours |
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| Primary | Pain Measurement Through VAS (Visual Analogue Score) at Rest | pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10) | Posted | Mean | Standard Deviation | score on a scale | 24-hours |
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| Secondary | Time to 100ft Ambulation After Surgery | Time to ambulation after surgery (ability to walk 100 feet). | Posted | Mean | Standard Deviation | minutes | Post-operative 12-32 hours |
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| Secondary | Time to Consumption of the First Opioid After Surgery. | Time to consumption of the first opioid after surgery. | Posted | Mean | Standard Deviation | minutes | 24 hours |
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| Secondary | Time to Hospital Discharge | Time to hospital discharge following surgery, measured in minutes | Posted | Mean | Standard Deviation | minutes | Post-operative day 1 to post-operative day 5 |
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Adverse event data was collected up until the time of patient discharge, roughly 24-hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Volume Group | 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 mL | 0 | 29 | 0 | 29 | 0 | 29 |
| EG001 | High Volume Group | 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL | 0 | 31 | 0 | 31 | 0 | 31 |
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This was a single hospital trial, and external validity may be attenuated. THA is a relatively standardized procedure with similar patient care in the operating room, PACU, and floor ward. With only 60 patients total, this study is underpowered, and the wide standard deviations suggest a need for a much larger study.
Pain score reported as the worst score over the previous 3 hours (interval) and reflects pain at rest post PT activity as day progresses, what may decrease the accuracy of report.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Uskova, MD | UPMC Department of Anesthesiology and Perioperative Medicine | 412-623-2167 | uskoaa@upmc.edu |
| Mar 25, 2024 |
| Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2020 | Mar 25, 2024 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D061846 | Hospitals, Low-Volume |
| D061847 | Hospitals, High-Volume |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006761 | Hospitals |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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