Quadratus Lumborum BlockPhase 4NCT03496610
Surgeon Infiltration QL Block Comparison
A Phase 4 study testing Liposomal Bupivicaine and QL Block in people with Quadratus Lumborum Block and Surgical Wound Infiltration, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quadratus Lumborum Block, Surgical Wound Infiltration
- What is being tested?
- Liposomal Bupivicaine and QL Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 23 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- ASA 1-2 patients undergoing living donor nephrectomy
Who cannot join
- ASA 3 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use)
- Inability to communicate pain scores or need for analgesia
- Infection at the site of block placement
- Pregnant women (as determined by standard of care day-of surgery urine bHCG)
Show all 11Show fewer
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients
The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.
- Being tested
- Liposomal Bupivicaine, QL Block
- Keywords
- Bupivacaine, Living donor nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivicaineDrug
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
QL BlockProcedure or surgery
Patient will receive ultrasound guided QL Block
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum (QL) Block | Active comparator | Patients will receive a bilateral ultrasound guided QL block by the anesthesia team. Receives: Procedure: QL Block |
| Surgical wound infiltration | Active comparator | Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon. Receives: Drug: Liposomal Bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
Measured: 24 hours postoperatively
Secondary outcomes (3)
Self-reported Numeric Pain Scores on Postoperative Day Seven
Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.
Measured: Postoperative day 7
Worst Bloating Severity in the First Postoperative Week
Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.
Measured: First seven days postoperatively
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes "without any difficulty" at any time during the first postoperative week is reported.
Measured: First seven days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start25 Jan 2021
- Primary completion23 Feb 2023
- Study completion23 Feb 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 Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector Martinez-Wilson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496610
- Sponsor's protocol ID
- Pro00087144
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2018
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03496610
- Acronym / sponsor ID
- Pro00087144
- Keywords
- Bupivacaine, Living donor nephrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum (QL) Block | Active comparator | Procedure: QL BlockPatients will receive a bilateral ultrasound guided QL block by the anesthesia team. |
| Surgical wound infiltration | Active comparator | Drug: Liposomal BupivicainePatients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- ASA 1-2 patients undergoing living donor nephrectomy
Key exclusion criteria (11 listed)
- ASA 3 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use)
- Inability to communicate pain scores or need for analgesia
- Infection at the site of block placement
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 |
|---|---|---|
| Liposomal BupivicainePatient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound | Drug | Surgical wound infiltration |
| QL BlockPatient will receive ultrasound guided QL Block | Procedure or surgery | Quadratus Lumborum (QL) Block |
Primary outcome
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
Time frame: 24 hours postoperatively
3 secondary outcomes
Self-reported Numeric Pain Scores on Postoperative Day Seven
Time frame: Postoperative day 7
Worst Bloating Severity in the First Postoperative Week
Time frame: First seven days postoperatively
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
Time frame: First seven days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hector Martinez-Wilson, MD principal investigator
Duke University
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 Liposomal Bupivicaine and QL Block in people with Quadratus Lumborum Block and Surgical Wound Infiltration, run by Duke University 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 2 inclusion and 11 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 5 Mar 2024. 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 5 Mar 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?
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.