Not provided
Not provided
Not provided
Not provided
Not provided
PI left the institution. Decision made to close the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Standard of Care | Active Comparator | Group I will receive the standard of care 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection Location 1 | Drug | Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Dose of the opioids consumed | 12 hours |
| Opioid Consumption | Dose of the opioids consumed | 24 hours |
| Opioid Consumption | Dose of the opioids consumed | 36 hours |
| Opioid Consumption | Dose of the opioids consumed | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 0 Hours |
| Pain Scale | Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eman Nada, MD | University of Massachusetts, Worcester | Principal Investigator |
| Alexander Chan, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
There is no plan to share individual participant data with other researchers. However, results of the study will be shared through publication.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Standard of Care | Group I will receive the standard of care multimodal pharmacological management. Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| FG001 | Group 2 Standard of Care + Quadratus Lumborum Block II | Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1 Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| FG002 | Group 3 Standard of Care + Quadratus Lumborum Block III | 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. Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per participant flow, 0 Group 1 participants are included in analysis population. The data from two patients in Group I was NOT collected because there was a protocol violation; one patient received Ketamine intraoperatively and the other patient received large amounts of local anesthetics in the wound.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Standard of Care | Group I will receive the standard of care multimodal pharmacological management. Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| BG001 | Group 2 Standard of Care + Quadratus Lumborum Block II |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Opioid Consumption | Dose of the opioids consumed | 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. | Posted | Mean | Full Range | morphine milligram equivalents | 12 hours |
|
4 months, 14 days. This is equal to the specified time the study was conducted.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Standard of Care | Group I will receive the standard of care multimodal pharmacological management. Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alexander Chan for Eman Nada, MD | UMass Chan Medical School | 7743030338 | alexander.chan@umassmemorial.org |
Not provided
| 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 | Sep 17, 2018 | Jun 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2021 | May 5, 2023 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
We will randomize 10 patients into one of three groups for a total of 30 patients. Each patient will be longitudinally followed until discharge.
Not provided
Not provided
For the blinding purposes, the patients will be told that there are two possible sites at which they will receive the block. The sites will be either in the operating room before you wake up from anesthesia or in the post-anesthesia care unit (PACU). The patients on the medical management group will be told that they have received their block before recovering from anesthesia, the PACU nurse will be told the same as well to make him or her blinded as a pain assessor.
|
| Ropivacaine injection Location 2 | Drug | Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 |
|
|
| Multimodal Pharmacological Management | Drug | standard of care multimodal pharmacological management |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 48 hours |
| Discharge Opioid Use | The amount of left-over opioid pills at 2 weeks in the follow up visit. | 2 weeks |
| Number of Participants Experiencing Side Effects | Number of Participants who experienced side effects. | Up to 1 week |
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1 Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| BG002 | Group 3 Standard of Care + Quadratus Lumborum Block III | 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. Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Multimodal Pharmacological Management: standard of care multimodal pharmacological management
| OG002 | Group 3 Standard of Care + Quadratus Lumborum Block III | 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. Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 Multimodal Pharmacological Management: standard of care multimodal pharmacological management |
|
|
| Primary | Opioid Consumption | Dose of the opioids consumed | 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. | Posted | Mean | Full Range | Morphine milligram equivalents | 24 hours |
|
|
|
| Primary | Opioid Consumption | Dose of the opioids consumed | 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. | Posted | Mean | Full Range | Morphine milligram equivalents | 36 hours |
|
|
|
| Primary | Opioid Consumption | Dose of the opioids consumed | 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. | Posted | Mean | Full Range | Morphine milligram equivalents | 48 hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 0 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 1 Hour |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 6 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 12 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 18 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 24 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 30 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 36 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. | Posted | Mean | Full Range | score on a scale | 42 Hours |
|
|
|
| Secondary | Pain Scale | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. | 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. Not able to collect data on a Group 2 participant due to timing and discharge. | Posted | Mean | Full Range | score on a scale | 48 hours |
|
|
|
| Secondary | Discharge Opioid Use | The amount of left-over opioid pills at 2 weeks in the follow up visit. | 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. | Posted | 2 weeks |
|
|
| Secondary | Number of Participants Experiencing Side Effects | Number of Participants who experienced side effects. | 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. | Posted | Number | participants | Up to 1 week |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Group 2 Standard of Care + Quadratus Lumborum Block II | Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Ropivacaine injection Location 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1 Multimodal Pharmacological Management: standard of care multimodal pharmacological management | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Group 3 Standard of Care + Quadratus Lumborum Block III | 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. Ropivacaine injection Location 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 Multimodal Pharmacological Management: standard of care multimodal pharmacological management | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| Aniline Compounds |
| D000588 | Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |