A Phase 4 interventional study of Quadratus Lumborum Block and Standard Medical Management in Pain, Postoperative and Opioid Use, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Other
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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Exclusion Criteria:
Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.
Combination Product: Quadratus Lumborum Block · Procedure: Standard Medical Management
Subjects will receive Intervention: Procedure: Standard Medical Management as needed.
Procedure: Standard Medical Management
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.
Also known as: QLB
Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
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.
Time frame: 24 hours
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.
Time frame: PACU, POD1, POD2, POD7
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.
Time frame: 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.
Time frame: 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.
Time frame: PACU, POD1, POD2, POD7
Time in PACU
Duration of patients' time in PACU.
Time frame: 48 hours
Postoperative Time to Discharge
Total postoperative time until discharge.
Time frame: 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.
Time frame: 12 hours
Number of Participants Who Report Nausea in PACU
Patient will be questioned to assess if they have nausea in PACU.
Time frame: 12 hours
Total Antiemetic Consumption on POD 0 and in PACU
Total consumption of antiemetics on POD 0 and in PACU.
Time frame: 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
Time frame: 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.
Time frame: POD1, POD2, POD7
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Total consumption of Non-Opioid Analgesics in the PACU.
Time frame: 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.
Time frame: 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.
Time frame: 6 hours
| Milestone | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Started | 8 | 6 |
| Completed | 8 | 6 |
| Not completed | 0 | 0 |
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.
| score on a scale | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Postoperative Day (POD) 1 Pain Score | 3.7857 ± 1.643 | 4.015 ± 2.291 |
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.
| score on a scale | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Pain Score at Rest PACU | 7.5833 ± 2.224 | 7.12 ± 1.443 |
| Pain at Rest POD 1 | 3.88 ± 1.64 | 3.50 ± 2.25 |
| Pain at Rest POD 2 | 3.33 ± 0.96 | 3.00 ± 1.73 |
| Pain at Rest POD 7 | 1.43 ± 1.03 | 1.57 ± 1.34 |
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.
| score on a scale | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Pain Score with Activity POD 1 | 7.07 ± 2.20 | 6.75 ± 1.97 |
| Pain Score with Activity POD 2 | 7.00 ± 2.57 | 5.58 ± 1.41 |
| Pain Score with Activity POD 7 | 3.5712 ± 2.012 | 3.670 ± 1.155 |
Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
| OMME | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Opioid Consumption in PACU | 28.93 ± 25.65 | 36.64 ± 16.70 |
| Opioid Consumption POD 1 | 24.58 ± 15.31 | 19.50 ± 2.89 |
| Opioid Consumption POD 2 | 27.50 ± 17.00 | 20.50 ± 5.77 |
| Opioid Consumption POD 7 | 58 ± 79.88 | 66.5 ± 37.27 |
Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.
| Participants | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| PACU — around navel | 4 | 2 |
| PACU — incision area | 2 | 2 |
| PACU — abdomen | 0 | 0 |
| PACU — navel | 0 | 1 |
| PACU — stomach area | 0 | 0 |
| PACU — middle of abomen | 0 | 0 |
| PACU — middle | 0 | 0 |
| POD 1 — around navel | 0 | 0 |
| POD 1 — incision area | 2 | 2 |
| POD 1 — abdomen | 2 | 2 |
| POD 1 — navel | 0 | 0 |
| POD 1 — stomach area | 1 | 0 |
| POD 1 — middle of abomen | 1 | 0 |
| POD 1 — middle | 1 | 0 |
| POD 2 — around navel | 1 | 1 |
| POD 2 — incision area | 3 | 2 |
| POD 2 — abdomen | 1 | 2 |
| POD 2 — navel | 0 | 0 |
| POD 2 — stomach area | 0 | 1 |
| POD 2 — middle of abomen | 2 | 0 |
| POD 2 — middle | 0 | 0 |
| POD 7 — around navel | 0 | 0 |
| POD 7 — incision area | 3 | 2 |
| POD 7 — abdomen | 0 | 2 |
| POD 7 — navel | 0 | 1 |
| POD 7 — stomach area | 2 | 0 |
| POD 7 — middle of abomen | 0 | 0 |
| POD 7 — middle | 0 | 0 |
Duration of patients' time in PACU.
| minutes | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Time in PACU | 66.63 ± 28.58 | 64.33 ± 26.82 |
Total postoperative time until discharge.
| hours | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Postoperative Time to Discharge | 66.625 ± 28.58 | 66.60 ± 26.82 |
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.
No measurements were reported for this outcome.
Patient will be questioned to assess if they have nausea in PACU.
| Participants | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Number of Participants Who Report Nausea in PACU | 2 | 0 |
Total consumption of antiemetics on POD 0 and in PACU.
No measurements were reported for this outcome.
Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7
| Participants | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| POD 1 | 5 | 4 |
| POD 2 | 0 | 0 |
| POD 7 | 0 | 0 |
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.
| score on a scale | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Rating of Satisfaction with perioperative care POD 1 | 8.60 ± 0.97 | 9.20 ± 1.14 |
| Rating of Satisfaction with perioperative care POD 2 | 8.83 ± 0.96 | 9.17 ± 1.91 |
| Rating of Satisfaction with perioperative care POD 7 | 9.21 ± 1.096 | 8.61 ± 1.768 |
Total consumption of Non-Opioid Analgesics in the PACU.
| milligrams | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Ketorolac | 0 ± 0 | 5 ± 12.25 |
| lidocaine in mg | 0 ± 0 | 0 ± 0 |
| acetaminophen in mg | 235.71 ± 415.04 | 333.33 ± 440.17 |
This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.
| milliliters | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Additional Analgesics in Milliliters Administered in the Operating Room | 0 ± 0 | 15.00 ± 16.43 |
This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.
| milligrams | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| Ketorolac | 8.57 ± 8.02 | 2.50 ± 6.12 |
| Acetaminophen | 166.67 ± 408.25 | 0 ± 0 |
| Propofol | 0.00 ± 0.00 | 28.33 ± 69.40 |
| lidocaine | 17.50 ± 36.15 | 20.00 ± 40.00 |
Collected over up to Post-operative day 7 (POD7). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| QLB + Medical Management | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Standard Medical Management | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | QLB + Medical Management | Standard Medical Management |
|---|---|---|
| incision site bleedingGeneral disorders | 0/8 | 1/6 |
| tirednessGeneral disorders | 0/8 | 1/6 |
| Age, Continuous(years) | QLB + Medical Management | Standard Medical Management | Total |
|---|---|---|---|
| Mean | 49.38 (25 to 68) | 56.17 (40 to 67) | 54.69 (25 to 68) |
| Sex: Female, Male(Participants) | QLB + Medical Management | Standard Medical Management | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | QLB + Medical Management | Standard Medical Management | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 6 | 14 |
| Race (NIH/OMB)(Participants) | QLB + Medical Management | Standard Medical Management | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 6 | 14 |
| Region of Enrollment(participants) | QLB + Medical Management | Standard Medical Management | Total |
|---|---|---|---|
| United States | 8 | 6 | 14 |
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