Acute PainPhase 4NCT04259645

Volume Versus Concentration: Clinical Effectiveness of Single Shot Quadrates Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.

A Phase 4 study testing Drug: Bupivacaine 0.375% 20 mL and Drug: Bupivacaine 0.375% diluted to 0.1875% in people with Acute Pain, run by Anna Uskova at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Acute Pain
What is being tested?: Drug: Bupivacaine 0.375% 20 mL and Drug: Bupivacaine 0.375% diluted to 0.1875%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: 1 Apr 2021to 30 Jan 2023
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 18-80 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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of pittsburgh
Pittsburgh, Pennsylvania, 15213
UPMC shadyside hospital
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Volume Versus Concentration: A Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Single Shot Quadratus Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.

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.

Read the detailed description

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.

Conditions: Acute Pain
Being tested: Drug: Bupivacaine 0.375% 20 mL, Drug: Bupivacaine 0.375% diluted to 0.1875%
Keywords: Hip, Anesthesia,conduction, arthroplasty
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug: Bupivacaine 0.375% 20 mLDrug
Also called Low Volume
20 mL 0.375% Bupivacaine
Drug: Bupivacaine 0.375% diluted to 0.1875%Drug
Also called High Volume
Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL)

Study groups in NCT04259645
Study group	Role	What they receive
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%. Receives: Drug: Drug: Bupivacaine 0.375% diluted to 0.1875%
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%). Receives: Drug: Drug: Bupivacaine 0.375% 20 mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Consumption of Opioids During the First 24 Hours After Surgery.
Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent
Measured: 24 hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest
pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)
Measured: 3-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest
pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)
Measured: 6-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest
pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)
Measured: 12-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest
pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)
Measured: 24-hours

Secondary outcomes (3)

Time to 100ft Ambulation After Surgery
Time to ambulation after surgery (ability to walk 100 feet).
Measured: Post-operative 12-32 hours
Time to Consumption of the First Opioid After Surgery.
Time to consumption of the first opioid after surgery.
Measured: 24 hours
Time to Hospital Discharge
Time to hospital discharge following surgery, measured in minutes
Measured: Post-operative day 1 to post-operative day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202130 Jan 2023

First posted6 Feb 2020
Study start1 Apr 2021
Primary completion30 Jan 2023
Study completion30 Jan 2023

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.
Other trials for Acute PainStudies 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: The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259645
Sponsor's protocol ID: STUDY19090192
Status last verified: Jun 2024
First submitted: 4 Feb 2020
Last updated: 10 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: There is no plan to share individual participant data

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Volume Versus Concentration: A Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Single Shot Quadratus Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.
ClinicalTrials.gov ID: NCT04259645
Acronym / sponsor ID: STUDY19090192
Conditions: Acute Pain
Keywords: Hip, Anesthesia,conduction, arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Anna UskovaUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 6 Feb 2020 (actual)
Results: Posted 10 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.

Arm	Type	Receives
Low Volume group	Active comparator	Drug: Drug: Bupivacaine 0.375% diluted to 0.1875%30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each subject received 20mL Bupivacaine 0.375%.
High Volume group	Experimental	Drug: Drug: Bupivacaine 0.375% 20 mL30 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%).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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.

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
Drug: Bupivacaine 0.375% 20 mLAlso: Low Volume20 mL 0.375% Bupivacaine	Drug	High Volume group
Drug: Bupivacaine 0.375% diluted to 0.1875%Also: High VolumeEach block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL)	Drug	Low Volume group

Primary outcome

Consumption of Opioids During the First 24 Hours After Surgery.
Time frame: 24 hours
Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent
Pain Measurement Through VAS (Visual Analogue Score) at Rest
Time frame: 3-hours
pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)
Pain Measurement Through VAS (Visual Analogue Score) at Rest
Time frame: 6-hours
pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)
Pain Measurement Through VAS (Visual Analogue Score) at Rest
Time frame: 12-hours
pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)
Pain Measurement Through VAS (Visual Analogue Score) at Rest
Time frame: 24-hours
pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)

3 secondary outcomes

Time to 100ft Ambulation After Surgery
Time frame: Post-operative 12-32 hours
Time to Consumption of the First Opioid After Surgery.
Time frame: 24 hours
Time to Hospital Discharge
Time frame: Post-operative day 1 to post-operative day 5

Results and safety

Results posted to the registry on 10 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Volume Group	29	29
High Volume Group	31	31

Primary outcome: Consumption of Opioids During the First 24 Hours After Surgery.

Time frame: 24 hours. Mean (Standard Deviation). Unit: mg morphine equivalents per 24 hours

Measure	Low Volume Group n = 29	High Volume Group n = 31
Value	46.2 (25.9)	35.0 (27.1)

Primary outcome: Pain Measurement Through VAS (Visual Analogue Score) at Rest

Time frame: 3-hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Low Volume Group n = 29	High Volume Group n = 31
Value	4.52 (2.76)	4.48 (2.81)

Primary outcome: Pain Measurement Through VAS (Visual Analogue Score) at Rest

Time frame: 6-hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Low Volume Group n = 29	High Volume Group n = 31
Value	5.76 (2.71)	5.08 (2.21)

Primary outcome: Pain Measurement Through VAS (Visual Analogue Score) at Rest

Time frame: 12-hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Low Volume Group n = 29	High Volume Group n = 31
Value	5.52 (2.23)	5.59 (2.83)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected up until the time of patient discharge, roughly 24-hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Volume Group	0 of 29 (0%)	0 of 29 (0%)	0 of 29
High Volume Group	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share individual participant data

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
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Not yet recruiting
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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.

Anna Uskova, MD principal investigator

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Drug: Bupivacaine 0.375% 20 mL and Drug: Bupivacaine 0.375% diluted to 0.1875% in people with Acute Pain, run by Anna Uskova at 2 sites 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 1 inclusion and 2 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 10 Jul 2024). 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?

Consumption of Opioids During the First 24 Hours After Surgery. (time frame: 24 hours). The study lists 5 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 NCT04259645.

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 10 Jul 2024.