Pain, Postoperative, Opioid Use
Conditions
Keywords
Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain
Brief summary
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.
Detailed description
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.
Interventions
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.
Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Sponsors
Study design
Masking description
The participant is blinded to the treatment.
Intervention model description
Parallel Assignment
Eligibility
Inclusion criteria
1. The subject is scheduled for elective laparoscopic ventral hernia repair; 2. The subject is ≥ 18 years and ≤ 80 years; 3. The patient agrees to receive a quadratus lumborum block 4. American Society of Anesthesiologists class 1-3.
Exclusion criteria
1. Subject is \< 18 years of age or \>80 years of age; 2. Subject is non-English speaking; 3. Subject is known or believed to be pregnant; 4. Subject is a prisoner; 5. Subject has impaired decision-making capacity per discretion of the Investigator; 6. Significant renal, cardiac or hepatic disease per discretion of the investigator; 7. American Society of Anesthesiologists class 4-5; 8. Known hypersensitivity and/or allergies to local anesthetics; 9. Chronic opioid use (daily or almost daily use of opioids for \> 3 months at any point in their lives). 10. Repair of a recurrent ventral hernia 11. Repair of multiple ventral hernias 12. Unobtainable sonographic views 13. Lacking health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Day (POD) 1 Pain Score | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | PACU, POD1, POD2, POD7 | Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7. |
| Location of Most Severe Pain | PACU, POD1, POD2, POD7 | Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7. |
| Pain Score at Rest | PACU, POD1, POD2, POD7 | 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 in PACU | 48 hours | Duration of patients' time in PACU. |
| Postoperative Time to Discharge | 72 hours | Total postoperative time until discharge. |
| Numbness Distribution in PACU | 12 hours | 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. |
| Pain Score With Activity | PACU, POD1, POD2, POD7 | 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. |
| Total Antiemetic Consumption on POD 0 and in PACU | 12 hours | Total consumption of antiemetics on POD 0 and in PACU. |
| Number of Participants With Presence of Nausea Necessitating Treatment | POD1, POD2, POD7 | Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7 |
| Rating of Satisfaction With Perioperative Care | POD1, POD2, POD7 | 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. |
| Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | 12 hours | Total consumption of Non-Opioid Analgesics in the PACU. |
| Additional Analgesics in Milliliters Administered in the Operating Room | 6 hours | This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room. |
| Additional Analgesics in Milligrams Administered in the Operating Room | 6 hours | This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room. |
| Number of Participants Who Report Nausea in PACU | 12 hours | Patient will be questioned to assess if they have nausea in PACU. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | QLB + Medical Management | Total | Standard Medical Management |
|---|---|---|---|
| Age, Continuous | 49.38 years | 54.69 years | 56.17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 14 Participants | 6 Participants |
| 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 | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 8 participants | 14 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 1 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
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
Population: Not all participants answered the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QLB + Medical Management | Postoperative Day (POD) 1 Pain Score | 3.7857 score on a scale | Standard Deviation 1.643 |
| Standard Medical Management | Postoperative Day (POD) 1 Pain Score | 4.015 score on a scale | Standard Deviation 2.291 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Ketorolac | 8.57 milligrams | Standard Deviation 8.02 |
| QLB + Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Acetaminophen | 166.67 milligrams | Standard Deviation 408.25 |
| QLB + Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Propofol | 0.00 milligrams | Standard Deviation 0 |
| QLB + Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | lidocaine | 17.50 milligrams | Standard Deviation 36.15 |
| Standard Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | lidocaine | 20.00 milligrams | Standard Deviation 40 |
| Standard Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Ketorolac | 2.50 milligrams | Standard Deviation 6.12 |
| Standard Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Propofol | 28.33 milligrams | Standard Deviation 69.4 |
| Standard Medical Management | Additional Analgesics in Milligrams Administered in the Operating Room | Acetaminophen | 0 milligrams | Standard Deviation 0 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QLB + Medical Management | Additional Analgesics in Milliliters Administered in the Operating Room | 0 milliliters | Standard Deviation 0 |
| Standard Medical Management | Additional Analgesics in Milliliters Administered in the Operating Room | 15.00 milliliters | Standard Deviation 16.43 |
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
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | middle | 1 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | abdomen | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | around navel | 1 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | middle | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | incision area | 3 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | stomach area | 2 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | abdomen | 1 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | incision area | 2 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | navel | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | navel | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | stomach area | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | abdomen | 2 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | middle of abomen | 2 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | incision area | 2 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 2 | middle | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | navel | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | around navel | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | stomach area | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | incision area | 3 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | stomach area | 1 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | abdomen | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | around navel | 4 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | navel | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | middle of abomen | 1 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | middle of abomen | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | PACU | middle of abomen | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 7 | middle | 0 Participants |
| QLB + Medical Management | Location of Most Severe Pain | POD 1 | around navel | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | middle | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | around navel | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | stomach area | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | around navel | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | incision area | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | abdomen | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | navel | 1 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | stomach area | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | middle of abomen | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | PACU | middle | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | incision area | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | abdomen | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | navel | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | stomach area | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | middle of abomen | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 1 | middle | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | around navel | 1 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | incision area | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | abdomen | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | navel | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | stomach area | 1 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | middle of abomen | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 2 | middle | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | around navel | 0 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | incision area | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | abdomen | 2 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | navel | 1 Participants |
| Standard Medical Management | Location of Most Severe Pain | POD 7 | middle of abomen | 0 Participants |
Number of Participants Who Report Nausea in PACU
Patient will be questioned to assess if they have nausea in PACU.
Time frame: 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB + Medical Management | Number of Participants Who Report Nausea in PACU | 2 Participants |
| Standard Medical Management | Number of Participants Who Report Nausea in PACU | 0 Participants |
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
Population: Data was not collected from all participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QLB + Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 1 | 5 Participants |
| QLB + Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 2 | 0 Participants |
| QLB + Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 7 | 0 Participants |
| Standard Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 1 | 4 Participants |
| Standard Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 2 | 0 Participants |
| Standard Medical Management | Number of Participants With Presence of Nausea Necessitating Treatment | POD 7 | 0 Participants |
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
Population: This question was not asked by the clinical team at 12 hours and therefore, no data can be entered for this aim.
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
Population: 3 participants from the QLB + Management Group did not respond to the 7 day OMME question.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption in PACU | 28.93 OMME | Standard Deviation 25.65 |
| QLB + Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 1 | 24.58 OMME | Standard Deviation 15.31 |
| QLB + Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 2 | 27.50 OMME | Standard Deviation 17 |
| QLB + Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 7 | 58 OMME | Standard Deviation 79.88 |
| Standard Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 7 | 66.5 OMME | Standard Deviation 37.27 |
| Standard Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption in PACU | 36.64 OMME | Standard Deviation 16.7 |
| Standard Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 2 | 20.50 OMME | Standard Deviation 5.77 |
| Standard Medical Management | Opioid Consumption in Oral Morphine Milligram Equivalent (OMME) | Opioid Consumption POD 1 | 19.50 OMME | Standard Deviation 2.89 |
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
Population: Not all participants answered the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Pain Score at Rest | Pain at Rest POD 2 | 3.33 score on a scale | Standard Deviation 0.96 |
| QLB + Medical Management | Pain Score at Rest | Pain Score at Rest PACU | 7.5833 score on a scale | Standard Deviation 2.224 |
| QLB + Medical Management | Pain Score at Rest | Pain at Rest POD 7 | 1.43 score on a scale | Standard Deviation 1.03 |
| QLB + Medical Management | Pain Score at Rest | Pain at Rest POD 1 | 3.88 score on a scale | Standard Deviation 1.64 |
| Standard Medical Management | Pain Score at Rest | Pain at Rest POD 7 | 1.57 score on a scale | Standard Deviation 1.34 |
| Standard Medical Management | Pain Score at Rest | Pain Score at Rest PACU | 7.12 score on a scale | Standard Deviation 1.443 |
| Standard Medical Management | Pain Score at Rest | Pain at Rest POD 2 | 3.00 score on a scale | Standard Deviation 1.73 |
| Standard Medical Management | Pain Score at Rest | Pain at Rest POD 1 | 3.50 score on a scale | Standard Deviation 2.25 |
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
Population: Not all participants answered survey questions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Pain Score With Activity | Pain Score with Activity POD 1 | 7.07 score on a scale | Standard Deviation 2.2 |
| QLB + Medical Management | Pain Score With Activity | Pain Score with Activity POD 7 | 3.5712 score on a scale | Standard Deviation 2.012 |
| QLB + Medical Management | Pain Score With Activity | Pain Score with Activity POD 2 | 7.00 score on a scale | Standard Deviation 2.57 |
| Standard Medical Management | Pain Score With Activity | Pain Score with Activity POD 2 | 5.58 score on a scale | Standard Deviation 1.41 |
| Standard Medical Management | Pain Score With Activity | Pain Score with Activity POD 1 | 6.75 score on a scale | Standard Deviation 1.97 |
| Standard Medical Management | Pain Score With Activity | Pain Score with Activity POD 7 | 3.670 score on a scale | Standard Deviation 1.155 |
| Unknown | Pain Score With Activity | Pain Score with Activity PACU | — score on a scale | — |
Postoperative Time to Discharge
Total postoperative time until discharge.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QLB + Medical Management | Postoperative Time to Discharge | 66.625 hours | Standard Deviation 28.58 |
| Standard Medical Management | Postoperative Time to Discharge | 66.60 hours | Standard Deviation 26.82 |
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
Population: Not all participants responded to the survey question.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 1 | 8.60 score on a scale | Standard Deviation 0.97 |
| QLB + Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 2 | 8.83 score on a scale | Standard Deviation 0.96 |
| QLB + Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 7 | 9.21 score on a scale | Standard Deviation 1.096 |
| Standard Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 1 | 9.20 score on a scale | Standard Deviation 1.14 |
| Standard Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 2 | 9.17 score on a scale | Standard Deviation 1.91 |
| Standard Medical Management | Rating of Satisfaction With Perioperative Care | Rating of Satisfaction with perioperative care POD 7 | 8.61 score on a scale | Standard Deviation 1.768 |
Time in PACU
Duration of patients' time in PACU.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QLB + Medical Management | Time in PACU | 66.63 minutes | Standard Deviation 28.58 |
| Standard Medical Management | Time in PACU | 64.33 minutes | Standard Deviation 26.82 |
Total Antiemetic Consumption on POD 0 and in PACU
Total consumption of antiemetics on POD 0 and in PACU.
Time frame: 12 hours
Population: 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.
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Total consumption of Non-Opioid Analgesics in the PACU.
Time frame: 12 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB + Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | Ketorolac | 0 milligrams | Standard Deviation 0 |
| QLB + Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | lidocaine in mg | 0 milligrams | Standard Deviation 0 |
| QLB + Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | acetaminophen in mg | 235.71 milligrams | Standard Deviation 415.04 |
| Standard Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | Ketorolac | 5 milligrams | Standard Deviation 12.25 |
| Standard Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | lidocaine in mg | 0 milligrams | Standard Deviation 0 |
| Standard Medical Management | Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams | acetaminophen in mg | 333.33 milligrams | Standard Deviation 440.17 |