Lumbar Disc Herniation, Opioid Use, Pain
Conditions
Keywords
Lumbar Spine, Nerve Block, Opioid Use, Pain
Brief 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.
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.
Interventions
DRUGRopivacaine injection Location 1
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
DRUGRopivacaine injection Location 2
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
DRUGMultimodal Pharmacological Management
standard of care multimodal pharmacological management
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult Patients undergoing lumbar spinal fusion surgery. * Patients from 40-80 years.
Exclusion criteria
* 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. * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 12 hours | Dose of the opioids consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale | 0 Hours | Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable. |
| Discharge Opioid Use | 2 weeks | The amount of left-over opioid pills at 2 weeks in the follow up visit. |
| Number of Participants Experiencing Side Effects | Up to 1 week | Number of Participants who experienced side effects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| 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 | 4 |
| 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 | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Issues with anesthesia during surgery | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1 Standard of Care | Group 2 Standard of Care + Quadratus Lumborum Block II | Group 3 Standard of Care + Quadratus Lumborum Block III | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Age, Continuous | — | 63.75 years | 73 years | 67.71 years |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | — | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 0 Participants | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | — | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | — | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Opioid Consumption
Dose of the opioids consumed
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Opioid Consumption | 31 Morphine milligram equivalents |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Opioid Consumption | 20 Morphine milligram equivalents |
Primary
Opioid Consumption
Dose of the opioids consumed
Time frame: 36 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Opioid Consumption | 35.625 Morphine milligram equivalents |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Opioid Consumption | 20 Morphine milligram equivalents |
Primary
Opioid Consumption
Dose of the opioids consumed
Time frame: 48 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Opioid Consumption | 31.875 Morphine milligram equivalents |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Opioid Consumption | 25 Morphine milligram equivalents |
Primary
Opioid Consumption
Dose of the opioids consumed
Time frame: 12 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Opioid Consumption | 30 morphine milligram equivalents |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Opioid Consumption | 17.5 morphine milligram equivalents |
Secondary
Discharge Opioid Use
The amount of left-over opioid pills at 2 weeks in the follow up visit.
Time frame: 2 weeks
Population: 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.
Secondary
Number of Participants Experiencing Side Effects
Number of Participants who experienced side effects.
Time frame: Up to 1 week
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Number of Participants Experiencing Side Effects | 4 participants |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Number of Participants Experiencing Side Effects | 3 participants |
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.
Time frame: 24 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 5.75 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 4.67 score on a scale |
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.
Time frame: 30 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 4.75 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 2.3 score on a scale |
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.
Time frame: 42 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 5.25 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 2 score on a scale |
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.
Time frame: 48 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 6 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 3.667 score on a scale |
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.
Time frame: 12 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 5.25 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 5.33 score on a scale |
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.
Time frame: 0 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 8 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 3.67 score on a scale |
Secondary
Pain Scale
Numerical Pain Scale Rating of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time frame: 1 Hour
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 4.75 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 2 score on a scale |
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.
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 5.25 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 2.33 score on a scale |
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.
Time frame: 36 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 6.25 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 6.33 score on a scale |
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.
Time frame: 18 Hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 Standard of Care + Quadratus Lumborum Block II | Pain Scale | 6 score on a scale |
| Group 3 Standard of Care + Quadratus Lumborum Block III | Pain Scale | 5.33 score on a scale |