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| ID | Type | Description | Link |
|---|---|---|---|
| A530900 | Other Identifier | UW Madison | |
| SMPH/ANESTHESIOLOGY/ANESTHESIO | Other Identifier | UW Madison | |
| Protocol Version 8/26/2019 | Other Identifier | UW Madison |
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administrative challenges and complications due to the COVID-19 pandemic
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Ventral hernia repair may be associated with significant postoperative pain. Pain is typically managed with intravenous (IV) and oral medications that come with their own risks, such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can improve pain scores, decrease the need for IV and oral pain medications, and/or speed the patients' return to normal activity.
Current trends in perioperative pain management stress the importance of multimodal analgesia in an effort to reduce the dependence on opioid pain medications. Adverse effects of opioids include sedation, respiratory depression, nausea, vomiting, constipation, itching, and, most importantly, the potential for tolerance and abuse. Multimodal analgesia attempts to utilize multiple techniques, including medications and nerve block procedures, to improve postoperative analgesia. Improved postoperative pain control can enable an earlier return to normal activities for patients, not only improving patient satisfaction, but also reducing postoperative morbidity and adverse effects of opioids.
Approximately 350,000 to 500,000 ventral hernia repairs are performed each year in the United States. Surgeries completed laparoscopically are typically performed on an outpatient basis, allowing patients to return home the same day of surgery and treat their pain independently with prescribed pain medications. Utilization of a regional anesthesia technique may allow prolonged numbing of the nerves postoperatively and decrease the reliance on oral pain medications. Transversus abdominis plane (TAP) blocks have been shown to decrease pain scores and opioid consumption following ventral hernia repair. Quadratus lumborum (QL) blocks are newer iterations of the TAP block.
There are currently three types of the QL block, all targeting the thoracolumbar fascia surrounding the quadratus lumborum muscle. Injection within this fascial plane may allow local anesthetic spread into the paravertebral space, possibly explaining why QL blocks have been mapped from the T7 to T12/L1 dermatomes, covering the entire abdomen. Conversely, TAP blocks have been mapped from the T10 to T12/L1 dermatomes, only covering the abdomen below the umbilicus. In the first, the Quadratus lumborum 1 block (QL1), the local anesthetic is injected within the fascial plane lateral to the QL muscle. In the second, the Quadratus lumborum 2 block (QL2), the needle trajectory is more superficial, and the local anesthetic is injected along the posterior border of the QL muscle. The third iteration, the Quadratus lumborum 3 block (QL3), involves a deeper, transmuscular approach with injection along the anterior border of the QL muscle. Our study would utilize the QL2 approach as the dermatomal distribution of the QL1 and QL2 blocks appear to be more widespread than the QL3 block, and the QL2 block may be a safer approach due to the more superficial angle of the needle 3.
Additionally, the QL block has been shown to have a longer duration of analgesia when directly compared to the TAP block. A study of pediatric lower abdominal surgery revealed improved pain scores and parent satisfaction with care in the QL group compared to TAP block. This improvement persisted to the 24 hour mark. In a study of postoperative pain following cesarean delivery, pain scores were improved and opioid consumption decreased with the QL block compared to the TAP block. The differences were not significant at the 1 and 6 hour marks, but were significant at the 12, 24 and 48 hour marks, highlighting the analgesic duration of the QL block 8.
This study aims to evaluate the efficacy of the QL block using the QL2 approach on recovery profile after laparoscopic ventral hernia repair, a commonly performed surgery, as well as contribute to the understanding of the block and its distribution of anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLB + Medical Management | Experimental | Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. |
|
| Standard Medical Management | Active Comparator | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadratus Lumborum Block | Combination Product | 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Day (POD) 1 Pain Score | Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at Rest | Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | PACU, POD1, POD2, POD7 |
| Pain Score With Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Bevil, MD | Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | QLB + Medical Management | Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
| FG001 | Standard Medical Management | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QLB + Medical Management | Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Postoperative Day (POD) 1 Pain Score | Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | Not all participants answered the survey. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
up to Post-operative day 7 (POD7)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QLB + Medical Management | Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| incision site bleeding | General disorders | Systematic Assessment | The subject reported incision site bleeding and tiredness at the 7 day time period. |
This study was terminated early due to the combined effects of the COVID-19 pandemic and the switching of the primary location for the procedure from UW Hospital to East Madison Hospital.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kristin Bevil | University of Wisconsin-Madison | 6082638100 | kbevil@wisc.edu |
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| 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 | Aug 26, 2019 | Jun 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006555 | Hernia, Ventral |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Parallel Assignment
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The participant is blinded to the treatment.
|
| Standard Medical Management | Procedure | Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
|
Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
| PACU, POD1, POD2, POD7 |
| Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7. | PACU, POD1, POD2, POD7 |
| Location of Most Severe Pain | Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7. | PACU, POD1, POD2, POD7 |
| Time in PACU | Duration of patients' time in PACU. | 48 hours |
| Postoperative Time to Discharge | Total postoperative time until discharge. | 72 hours |
| Numbness Distribution in PACU | For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point. | 12 hours |
| Number of Participants Who Report Nausea in PACU | Patient will be questioned to assess if they have nausea in PACU. | 12 hours |
| Total Antiemetic Consumption on POD 0 and in PACU | Total consumption of antiemetics on POD 0 and in PACU. | 12 hours |
| Number of Participants With Presence of Nausea Necessitating Treatment | Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7 | POD1, POD2, POD7 |
| Rating of Satisfaction With Perioperative Care | Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction. | POD1, POD2, POD7 |
| Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | Total consumption of Non-Opioid Analgesics in the PACU. | 12 hours |
| Additional Analgesics in Milliliters Administered in the Operating Room | This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room. | 6 hours |
| Additional Analgesics in Milligrams Administered in the Operating Room | This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room. | 6 hours |
| BG001 | Standard Medical Management | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Medical Management | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone |
|
|
| Secondary | Pain Score at Rest | Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | Not all participants answered the survey. | Posted | Mean | Standard Deviation | score on a scale | PACU, POD1, POD2, POD7 |
|
|
|
| Secondary | Pain Score With Activity | Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable. | Not all participants answered survey questions. | Posted | Mean | Standard Deviation | score on a scale | PACU, POD1, POD2, POD7 |
|
|
|
| Secondary | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7. | 3 participants from the QLB + Management Group did not respond to the 7 day OMME question. | Posted | Mean | Standard Deviation | OMME | PACU, POD1, POD2, POD7 |
|
|
|
| Secondary | Location of Most Severe Pain | Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7. | Two subjects on the expermental protocol and one in the control group were unable to provide the answers to this secondary aim question when asked by the study team. | Posted | Count of Participants | Participants | PACU, POD1, POD2, POD7 |
|
|
|
| Secondary | Time in PACU | Duration of patients' time in PACU. | Posted | Mean | Standard Deviation | minutes | 48 hours |
|
|
|
| Secondary | Postoperative Time to Discharge | Total postoperative time until discharge. | Posted | Mean | Standard Deviation | hours | 72 hours |
|
|
|
| Secondary | Numbness Distribution in PACU | For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point. | This question was not asked by the clinical team at 12 hours and therefore, no data can be entered for this aim. | Posted | 12 hours |
|
|
| Secondary | Number of Participants Who Report Nausea in PACU | Patient will be questioned to assess if they have nausea in PACU. | Posted | Count of Participants | Participants | 12 hours |
|
|
|
| Secondary | Total Antiemetic Consumption on POD 0 and in PACU | Total consumption of antiemetics on POD 0 and in PACU. | This secondary aim was not asked/followed up by the PI and therefore, the subjects were not asked this question and no data was collected for either time point. | Posted | 12 hours |
|
|
| Secondary | Number of Participants With Presence of Nausea Necessitating Treatment | Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7 | Data was not collected from all participants. | Posted | Count of Participants | Participants | POD1, POD2, POD7 |
|
|
|
| Secondary | Rating of Satisfaction With Perioperative Care | Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction. | Not all participants responded to the survey question. | Posted | Mean | Standard Deviation | score on a scale | POD1, POD2, POD7 |
|
|
|
| Secondary | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | Total consumption of Non-Opioid Analgesics in the PACU. | Posted | Mean | Standard Deviation | milligrams | 12 hours |
|
|
|
| Secondary | Additional Analgesics in Milliliters Administered in the Operating Room | This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room. | Posted | Mean | Standard Deviation | milliliters | 6 hours |
|
|
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| Secondary | Additional Analgesics in Milligrams Administered in the Operating Room | This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room. | Posted | Mean | Standard Deviation | milligrams | 6 hours |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Standard Medical Management | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone | 0 | 6 | 0 | 6 | 1 | 6 |
|
| tiredness | General disorders | Systematic Assessment | Overall tiredness |
|
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| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| Pain at Rest POD 1 |
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| Pain at Rest POD 2 |
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| Pain at Rest POD 7 |
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| Pain Score with Activity POD 2 |
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| Pain Score with Activity POD 7 |
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| Opioid Consumption POD 2 |
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| Opioid Consumption POD 7 |
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| incision area |
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| abdomen |
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| navel |
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| stomach area |
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| middle of abomen |
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| middle |
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| POD 1 |
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| POD 2 |
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| POD 7 |
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| POD 7 |
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| Rating of Satisfaction with perioperative care POD 7 |
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| acetaminophen in mg |
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| Propofol |
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| lidocaine |
|