Clinical trial NCT03794882: Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair
Official title: Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Opioid Use
Keywords: Hernia, Ventral
Pain, Postoperative
Opioid Use
Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Day (POD) 1 Pain Score
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Score at Rest
timeFrame: PACU, POD1, POD2, POD7
measure: Pain Score With Activity
timeFrame: PACU, POD1, POD2, POD7
measure: Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
timeFrame: PACU, POD1, POD2, POD7
measure: Location of Most Severe Pain
timeFrame: PACU, POD1, POD2, POD7
measure: Time in PACU
timeFrame: 48 hours
measure: Postoperative Time to Discharge
timeFrame: 72 hours
measure: Numbness Distribution in PACU
timeFrame: 12 hours
measure: Number of Participants Who Report Nausea in PACU
timeFrame: 12 hours
measure: Total Antiemetic Consumption on POD 0 and in PACU
timeFrame: 12 hours
measure: Number of Participants With Presence of Nausea Necessitating Treatment
timeFrame: POD1, POD2, POD7
measure: Rating of Satisfaction With Perioperative Care
timeFrame: POD1, POD2, POD7
measure: Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
timeFrame: 12 hours
measure: Additional Analgesics in Milliliters Administered in the Operating Room
timeFrame: 6 hours
measure: Additional Analgesics in Milligrams Administered in the Operating Room
timeFrame: 6 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
name: Kristin Bevil, MD
role: PRINCIPAL_INVESTIGATOR
References: