Lumbar RadiculopathyPhase 4NCT05417113
Erector Spinae Block for Spine Surgery
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine in people with Lumbar Radiculopathy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Liposomal bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to 27 Feb 2024
- Phase
- Phase 4
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged greater than or equal to 18 years old and less than or equal to 85 years old.
- Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.
Who cannot join
- Patients with a history of chronic opioid use for > 3 months including but not limited to fentanyl, morphine, oxycodone, methadone.
- Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications.
- Patients with a history of alcohol or drug abuse.
- Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.
- Patients with renal insufficiency.
- Patients who are pregnant.
- Patients with American Society of Anesthesiologists physical status of 4 or greater.
- Patients on immunosuppressive therapy. Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.
Read the detailed description
This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:
The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine
The secondary objectives include:
Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.
Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Liposomal bupivacaine, Bupivacaine
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
liposomal bupivacaine
BupivacaineDrug
bupivacaine 0.25% in ESP blocks
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine only | Active comparator | bupivacaine 0.25% in ESP blocks Receives: Drug: Bupivacaine |
| Liposomal Bupivacaine and Bupivacaine | Experimental | liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption During First 72 Hours
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Measured: 12 hours, 24 hours, 48 hours, 72 hours
Secondary outcomes (5)
Change in Pain Score
Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.
Measured: up to 12 weeks
Quality of Recovery (QOR 15)
Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.
Measured: 72 hours
Number of Participants With Postoperative Nausea/Vomiting (PONV)
Number of participants with postoperative nausea/vomiting (PONV) in PACU
Measured: in PACU (4 hours)
Time to Ambulation
Time to ambulation in hours
Measured: average 26-27 hours
Hospital Length of Stay
Hospital length of stay (LOS)
Measured: average 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start31 Aug 2022
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: recruitment difficulty
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 Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Jeng, Icahn School of Medicine at Mount Sinai
- Investigators
- Christina Jeng, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417113
- Sponsor's protocol ID
- STUDY-22-00168
- Status last verified
- May 2024
- First submitted
- 9 Jun 2022
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IRB approval was not obtained to share IPD.