PainPhase 3NCT04588389

Comparison of Quadratus Lumborum Block Types

A Phase 3 study testing Ropivacaine injection Location 1, Ropivacaine injection Location 2 and Multimodal Pharmacological Management in people with Pain and Opioid Use, run by University of Massachusetts, Worcester at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Pain, Opioid Use, Lumbar Disc Herniation
What is being tested?: Ropivacaine injection Location 1, Ropivacaine injection Location 2 and Multimodal Pharmacological Management
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 14 May 2021
Phase: Phase 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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult Patients undergoing lumbar spinal fusion surgery.
Patients from 40-80 years.

Who cannot join

Recent drug abuse
History of illicit drug use
Chronic pain patients not related to the back lesions.
Opioid tolerant patients.
Patients with any lower extremity weaknesses or deficits.
Patients with American Society of Anesthesiologists (ASA) classification more than 3.

Show all 14Show fewer

Coagulopathy.
Infection near or in the area of the block.
Pregnant patients.
Uncooperative patients who refuse care which directly effects research participation or clinical care.
If the surgeon reports performing non-typical fusion.
The presence of intraoperative complications like nerve injury or abnormal results of neuromonitoring and extensive dissection.
Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.)
Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control)

Trial locations and contacts

1 site in 1 country.

United States1 site

UMASS Memorial Medical Center
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery

Read the detailed description

This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.

Conditions: Pain, Opioid Use, Lumbar Disc Herniation
Being tested: Ropivacaine injection Location 1, Ropivacaine injection Location 2, Multimodal Pharmacological Management
Keywords: Lumbar Spine, Nerve Block, Opioid Use, Pain
Medical subject headings: Pain, Intervertebral Disc Displacement

What participants receive

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

Ropivacaine injection Location 1Drug
Also called Lidocaine
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Ropivacaine injection Location 2Drug
Also called Lidocaine
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Multimodal Pharmacological ManagementDrug
Also called Standard of Care
standard of care multimodal pharmacological management

Study groups in NCT04588389
Study group	Role	What they receive
Group 1 Standard of Care	Active comparator	Group I will receive the standard of care multimodal pharmacological management. Receives: Drug: Multimodal Pharmacological Management
Group 2 Standard of Care + Quadratus Lumborum Block II	Experimental	Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Receives: Drug: Ropivacaine injection Location 1; Drug: Multimodal Pharmacological Management
Group 3 Standard of Care + Quadratus Lumborum Block III	Experimental	Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient. Receives: Drug: Ropivacaine injection Location 2; Drug: Multimodal Pharmacological Management

What is being measured

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

Opioid Consumption
Dose of the opioids consumed
Measured: 12 hours
Opioid Consumption
Dose of the opioids consumed
Measured: 24 hours
Opioid Consumption
Dose of the opioids consumed
Measured: 36 hours
Opioid Consumption
Dose of the opioids consumed
Measured: 48 hours

Secondary outcomes (12)

Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 0 Hours
Pain Scale
Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 1 Hour
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 6 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 12 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 18 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 24 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 30 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 36 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 42 Hours
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Measured: 48 hours
Discharge Opioid Use
The amount of left-over opioid pills at 2 weeks in the follow up visit.
Measured: 2 weeks
Number of Participants Experiencing Side Effects
Number of Participants who experienced side effects.
Measured: Up to 1 week

Timeline

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

1 Dec 202014 May 2021

First posted19 Oct 2020
Study start1 Dec 2020
Primary completion14 May 2021
Study completion14 May 2021

Why it stopped: PI left the institution. Decision made to close the study.

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 PainStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: We will randomize 10 patients into one of three groups for a total of 30 patients. Each patient will be longitudinally followed until discharge.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04588389
Sponsor's protocol ID: H00016236
Status last verified: Jul 2025
First submitted: 30 Sep 2020
Last updated: 28 Jul 2025
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 with other researchers. However, results of the study will be shared through publication.

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

RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery
ClinicalTrials.gov ID: NCT04588389
Acronym / sponsor ID: H00016236
Conditions: Pain, Opioid Use, Lumbar Disc Herniation
Keywords: Lumbar Spine, Nerve Block, Opioid Use, Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI left the institution. Decision made to close the study.
Enrolment: 9 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Study start: 1 Dec 2020 (actual)
Primary completion: 14 May 2021 (actual)
Study completion: 14 May 2021 (actual)
First posted: 19 Oct 2020 (actual)
Results: Posted 28 Jul 2025

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: 3
Model description: We will randomize 10 patients into one of three groups for a total of 30 patients. Each patient will be longitudinally followed until discharge.

Arm	Type	Receives
Group 1 Standard of Care	Active comparator	Drug: Multimodal Pharmacological ManagementGroup I will receive the standard of care multimodal pharmacological management.
Group 2 Standard of Care + Quadratus Lumborum Block II	Experimental	Drug: Ropivacaine injection Location 1, Drug: Multimodal Pharmacological ManagementGroup II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Group 3 Standard of Care + Quadratus Lumborum Block III	Experimental	Drug: Ropivacaine injection Location 2, Drug: Multimodal Pharmacological ManagementGroup III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult Patients undergoing lumbar spinal fusion surgery.
Patients from 40-80 years.

Key exclusion criteria (14 listed)

Recent drug abuse
History of illicit drug use
Chronic pain patients not related to the back lesions.
Opioid tolerant patients.
Patients with any lower extremity weaknesses or deficits.

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
Ropivacaine injection Location 1Also: LidocaineRopivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1	Drug	Group 2 Standard of Care + Quadratus Lumborum Block II
Ropivacaine injection Location 2Also: LidocaineRopivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2	Drug	Group 3 Standard of Care + Quadratus Lumborum Block III
Multimodal Pharmacological ManagementAlso: Standard of Carestandard of care multimodal pharmacological management	Drug	Group 1 Standard of Care, Group 2 Standard of Care + Quadratus Lumborum Block II, Group 3 Standard of Care + Quadratus Lumborum Block III

Primary outcome

Opioid Consumption
Time frame: 12 hours
Dose of the opioids consumed
Opioid Consumption
Time frame: 24 hours
Dose of the opioids consumed
Opioid Consumption
Time frame: 36 hours
Dose of the opioids consumed
Opioid Consumption
Time frame: 48 hours
Dose of the opioids consumed

12 secondary outcomes

Pain Scale
Time frame: 0 Hours
Pain Scale
Time frame: 1 Hour
Pain Scale
Time frame: 6 Hours
Pain Scale
Time frame: 12 Hours
Pain Scale
Time frame: 18 Hours
Pain Scale
Time frame: 24 Hours
Pain Scale
Time frame: 30 Hours
Pain Scale
Time frame: 36 Hours
Pain Scale
Time frame: 42 Hours
Pain Scale
Time frame: 48 hours
Discharge Opioid Use
Time frame: 2 weeks
Number of Participants Experiencing Side Effects
Time frame: Up to 1 week

Results and safety

Results posted to the registry on 28 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Standard of Care	2	0
Group 2 Standard of Care + Quadratus Lumborum Block II	4	4
Group 3 Standard of Care + Quadratus Lumborum Block III	3	3

Primary outcome: Opioid Consumption

Time frame: 12 hours. Mean (Full Range). Unit: morphine milligram equivalents

Measure	Group 1 Standard of Care n = 0	Group 2 Standard of Care + Quadratus Lumborum Block II n = 4	Group 3 Standard of Care + Quadratus Lumborum Block III n = 3
Value	–	30 (7.5 to 37.5)	17.5 (7.5 to 22.5)

Population analysed: No data was collected on Participants in Group 1 and were excluded from analysis population as there were issues with anesthesia. One participant received a large amount of local anesthetics by surgeon and the other received ketamine in anesthesia.

Primary outcome: Opioid Consumption

Time frame: 24 hours. Mean (Full Range). Unit: Morphine milligram equivalents

Measure	Group 1 Standard of Care n = 0	Group 2 Standard of Care + Quadratus Lumborum Block II n = 4	Group 3 Standard of Care + Quadratus Lumborum Block III n = 3
Value	–	31 (7.5 to 56.25)	20 (15 to 37.5)

Primary outcome: Opioid Consumption

Time frame: 36 hours. Mean (Full Range). Unit: Morphine milligram equivalents

Measure	Group 1 Standard of Care n = 0	Group 2 Standard of Care + Quadratus Lumborum Block II n = 4	Group 3 Standard of Care + Quadratus Lumborum Block III n = 3
Value	–	35.625 (15 to 52.5)	20 (7.5 to 30)

Primary outcome: Opioid Consumption

Time frame: 48 hours. Mean (Full Range). Unit: Morphine milligram equivalents

Measure	Group 1 Standard of Care n = 0	Group 2 Standard of Care + Quadratus Lumborum Block II n = 4	Group 3 Standard of Care + Quadratus Lumborum Block III n = 3
Value	–	31.875 (15 to 45)	25 (15 to 30)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months, 14 days. This is equal to the specified time the study was conducted.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Standard of Care	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Group 2 Standard of Care + Quadratus Lumborum Block II	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 3 Standard of Care + Quadratus Lumborum Block III	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): Research project closed early due to departure of originating PI and despite departmental efforts, a new PI was not available to take over study. Study encountered coordination issues relative to Arm 1.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers. However, results of the study will be shared through publication.

Related trials for Pain

RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis

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.

Eman Nada, MD principal investigator

University of Massachusetts, Worcester

Alexander Chan, MD principal investigator

University of Massachusetts, Worcester

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

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Jul 2025. 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 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 28 Jul 2025). 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?

Opioid Consumption (time frame: 12 hours). The study lists 4 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 NCT04588389.

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 28 Jul 2025.