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Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair

Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03794882
Enrollment
14
Registered
2019-01-07
Start date
2019-05-06
Completion date
2020-03-12
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Opioid Use

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

COMBINATION_PRODUCTQuadratus Lumborum Block

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

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

The participant is blinded to the treatment.

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Postoperative Day (POD) 1 Pain Score24 hoursPain 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

MeasureTime frameDescription
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)PACU, POD1, POD2, POD7Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
Location of Most Severe PainPACU, POD1, POD2, POD7Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.
Pain Score at RestPACU, POD1, POD2, POD7Pain 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 PACU48 hoursDuration of patients' time in PACU.
Postoperative Time to Discharge72 hoursTotal postoperative time until discharge.
Numbness Distribution in PACU12 hoursFor 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 ActivityPACU, POD1, POD2, POD7Pain 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 PACU12 hoursTotal consumption of antiemetics on POD 0 and in PACU.
Number of Participants With Presence of Nausea Necessitating TreatmentPOD1, POD2, POD7Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7
Rating of Satisfaction With Perioperative CarePOD1, POD2, POD7Satisfaction 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 Milligrams12 hoursTotal consumption of Non-Opioid Analgesics in the PACU.
Additional Analgesics in Milliliters Administered in the Operating Room6 hoursThis measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.
Additional Analgesics in Milligrams Administered in the Operating Room6 hoursThis measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.
Number of Participants Who Report Nausea in PACU12 hoursPatient will be questioned to assess if they have nausea in PACU.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total14

Baseline characteristics

CharacteristicQLB + Medical ManagementTotalStandard Medical Management
Age, Continuous49.38 years54.69 years56.17 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants14 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants14 Participants6 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
8 participants14 participants6 participants
Sex: Female, Male
Female
3 Participants6 Participants3 Participants
Sex: Female, Male
Male
5 Participants8 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 6
other
Total, other adverse events
0 / 81 / 6
serious
Total, serious adverse events
0 / 80 / 6

Outcome results

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.

Time frame: 24 hours

Population: Not all participants answered the survey.

ArmMeasureValue (MEAN)Dispersion
QLB + Medical ManagementPostoperative Day (POD) 1 Pain Score3.7857 score on a scaleStandard Deviation 1.643
Standard Medical ManagementPostoperative Day (POD) 1 Pain Score4.015 score on a scaleStandard Deviation 2.291
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.

Time frame: 6 hours

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomKetorolac8.57 milligramsStandard Deviation 8.02
QLB + Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomAcetaminophen166.67 milligramsStandard Deviation 408.25
QLB + Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomPropofol0.00 milligramsStandard Deviation 0
QLB + Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating Roomlidocaine17.50 milligramsStandard Deviation 36.15
Standard Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating Roomlidocaine20.00 milligramsStandard Deviation 40
Standard Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomKetorolac2.50 milligramsStandard Deviation 6.12
Standard Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomPropofol28.33 milligramsStandard Deviation 69.4
Standard Medical ManagementAdditional Analgesics in Milligrams Administered in the Operating RoomAcetaminophen0 milligramsStandard Deviation 0
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.

Time frame: 6 hours

ArmMeasureValue (MEAN)Dispersion
QLB + Medical ManagementAdditional Analgesics in Milliliters Administered in the Operating Room0 millilitersStandard Deviation 0
Standard Medical ManagementAdditional Analgesics in Milliliters Administered in the Operating Room15.00 millilitersStandard Deviation 16.43
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.

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
QLB + Medical ManagementLocation of Most Severe PainPOD 1middle1 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUabdomen0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2around navel1 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUmiddle0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2incision area3 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7stomach area2 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2abdomen1 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1incision area2 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2navel0 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUnavel0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2stomach area0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1abdomen2 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2middle of abomen2 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUincision area2 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 2middle0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1navel0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7around navel0 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUstomach area0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7incision area3 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1stomach area1 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7abdomen0 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUaround navel4 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7navel0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1middle of abomen1 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7middle of abomen0 Participants
QLB + Medical ManagementLocation of Most Severe PainPACUmiddle of abomen0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 7middle0 Participants
QLB + Medical ManagementLocation of Most Severe PainPOD 1around navel0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7middle0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1around navel0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7stomach area0 Participants
Standard Medical ManagementLocation of Most Severe PainPACUaround navel2 Participants
Standard Medical ManagementLocation of Most Severe PainPACUincision area2 Participants
Standard Medical ManagementLocation of Most Severe PainPACUabdomen0 Participants
Standard Medical ManagementLocation of Most Severe PainPACUnavel1 Participants
Standard Medical ManagementLocation of Most Severe PainPACUstomach area0 Participants
Standard Medical ManagementLocation of Most Severe PainPACUmiddle of abomen0 Participants
Standard Medical ManagementLocation of Most Severe PainPACUmiddle0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1incision area2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1abdomen2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1navel0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1stomach area0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1middle of abomen0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 1middle0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2around navel1 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2incision area2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2abdomen2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2navel0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2stomach area1 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2middle of abomen0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 2middle0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7around navel0 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7incision area2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7abdomen2 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7navel1 Participants
Standard Medical ManagementLocation of Most Severe PainPOD 7middle of abomen0 Participants
Secondary

Number of Participants Who Report Nausea in PACU

Patient will be questioned to assess if they have nausea in PACU.

Time frame: 12 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
QLB + Medical ManagementNumber of Participants Who Report Nausea in PACU2 Participants
Standard Medical ManagementNumber of Participants Who Report Nausea in PACU0 Participants
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

Time frame: POD1, POD2, POD7

Population: Data was not collected from all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
QLB + Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 15 Participants
QLB + Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 20 Participants
QLB + Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 70 Participants
Standard Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 14 Participants
Standard Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 20 Participants
Standard Medical ManagementNumber of Participants With Presence of Nausea Necessitating TreatmentPOD 70 Participants
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.

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.

Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption in PACU28.93 OMMEStandard Deviation 25.65
QLB + Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 124.58 OMMEStandard Deviation 15.31
QLB + Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 227.50 OMMEStandard Deviation 17
QLB + Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 758 OMMEStandard Deviation 79.88
Standard Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 766.5 OMMEStandard Deviation 37.27
Standard Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption in PACU36.64 OMMEStandard Deviation 16.7
Standard Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 220.50 OMMEStandard Deviation 5.77
Standard Medical ManagementOpioid Consumption in Oral Morphine Milligram Equivalent (OMME)Opioid Consumption POD 119.50 OMMEStandard Deviation 2.89
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.

Time frame: PACU, POD1, POD2, POD7

Population: Not all participants answered the survey.

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementPain Score at RestPain at Rest POD 23.33 score on a scaleStandard Deviation 0.96
QLB + Medical ManagementPain Score at RestPain Score at Rest PACU7.5833 score on a scaleStandard Deviation 2.224
QLB + Medical ManagementPain Score at RestPain at Rest POD 71.43 score on a scaleStandard Deviation 1.03
QLB + Medical ManagementPain Score at RestPain at Rest POD 13.88 score on a scaleStandard Deviation 1.64
Standard Medical ManagementPain Score at RestPain at Rest POD 71.57 score on a scaleStandard Deviation 1.34
Standard Medical ManagementPain Score at RestPain Score at Rest PACU7.12 score on a scaleStandard Deviation 1.443
Standard Medical ManagementPain Score at RestPain at Rest POD 23.00 score on a scaleStandard Deviation 1.73
Standard Medical ManagementPain Score at RestPain at Rest POD 13.50 score on a scaleStandard Deviation 2.25
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.

Time frame: PACU, POD1, POD2, POD7

Population: Not all participants answered survey questions.

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementPain Score With ActivityPain Score with Activity POD 17.07 score on a scaleStandard Deviation 2.2
QLB + Medical ManagementPain Score With ActivityPain Score with Activity POD 73.5712 score on a scaleStandard Deviation 2.012
QLB + Medical ManagementPain Score With ActivityPain Score with Activity POD 27.00 score on a scaleStandard Deviation 2.57
Standard Medical ManagementPain Score With ActivityPain Score with Activity POD 25.58 score on a scaleStandard Deviation 1.41
Standard Medical ManagementPain Score With ActivityPain Score with Activity POD 16.75 score on a scaleStandard Deviation 1.97
Standard Medical ManagementPain Score With ActivityPain Score with Activity POD 73.670 score on a scaleStandard Deviation 1.155
UnknownPain Score With ActivityPain Score with Activity PACU score on a scale
Secondary

Postoperative Time to Discharge

Total postoperative time until discharge.

Time frame: 72 hours

ArmMeasureValue (MEAN)Dispersion
QLB + Medical ManagementPostoperative Time to Discharge66.625 hoursStandard Deviation 28.58
Standard Medical ManagementPostoperative Time to Discharge66.60 hoursStandard Deviation 26.82
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.

Time frame: POD1, POD2, POD7

Population: Not all participants responded to the survey question.

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 18.60 score on a scaleStandard Deviation 0.97
QLB + Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 28.83 score on a scaleStandard Deviation 0.96
QLB + Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 79.21 score on a scaleStandard Deviation 1.096
Standard Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 19.20 score on a scaleStandard Deviation 1.14
Standard Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 29.17 score on a scaleStandard Deviation 1.91
Standard Medical ManagementRating of Satisfaction With Perioperative CareRating of Satisfaction with perioperative care POD 78.61 score on a scaleStandard Deviation 1.768
Secondary

Time in PACU

Duration of patients' time in PACU.

Time frame: 48 hours

ArmMeasureValue (MEAN)Dispersion
QLB + Medical ManagementTime in PACU66.63 minutesStandard Deviation 28.58
Standard Medical ManagementTime in PACU64.33 minutesStandard Deviation 26.82
Secondary

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.

Secondary

Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams

Total consumption of Non-Opioid Analgesics in the PACU.

Time frame: 12 hours

ArmMeasureGroupValue (MEAN)Dispersion
QLB + Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in MilligramsKetorolac0 milligramsStandard Deviation 0
QLB + Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in Milligramslidocaine in mg0 milligramsStandard Deviation 0
QLB + Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in Milligramsacetaminophen in mg235.71 milligramsStandard Deviation 415.04
Standard Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in MilligramsKetorolac5 milligramsStandard Deviation 12.25
Standard Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in Milligramslidocaine in mg0 milligramsStandard Deviation 0
Standard Medical ManagementTotal Non-Opioid Analgesic Consumption in PACU: Measured in Milligramsacetaminophen in mg333.33 milligramsStandard Deviation 440.17

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026