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

• ClinicalTrials.gov Identifier: NCT03794882
• Recruitment Status: Terminated
• First Posted: January 7, 2019
• Last Update Posted: December 21, 2021
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Opioid Use	Procedure: Quadratus Lumborum Block; Procedure: Standard Medical Management	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair
• Actual Study Start Date: May 6, 2019
• Actual Primary Completion Date: March 12, 2020
• Actual Study Completion Date: March 12, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: QLB + Medical Management; Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.	Procedure: 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.; Other Name: QLB; Procedure: Standard Medical Management; Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Active Comparator: Standard Medical Management; Subjects will receive Intervention: Procedure: Standard Medical Management as needed.	Procedure: Standard Medical Management; Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone

Outcome Measures

Primary Outcome Measures :

1. Postoperative Day (POD) 1 Pain Score [ Time Frame: 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 Outcome Measures :

1. Pain Score at Rest [ Time Frame: 7 days ]
   Pain at rest on POD 0,2, 7 and in the Post Anesthesia Care Unit (PACU) using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
2. Pain Score with Activity [ Time Frame: 7 days ]
   Pain with activity on POD 0,1,2, 7 and in PACU assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
3. Opioid Consumption [ Time Frame: 7 days ]
   Opioid Consumption in morphine equivalents on POD 0,1,2,7 and in PACU
4. Location of most severe pain [ Time Frame: 7 days ]
   Location of most severe pain on assessed by questioning the patient on POD 1,2,7 and in PACU.
5. Time in PACU [ Time Frame: 48 hours ]
   Duration of patients' time in PACU.
6. Postoperative time to discharge. [ Time Frame: 48 hours ]
   Total postoperative time until discharge.
7. Numbness distribution in PACU [ Time Frame: 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.
8. Presence of Nausea in PACU [ Time Frame: 12 hours ]
   Patient will be questioned to assess if they have nausea in PACU.
9. Total Non-Opioid Analgesic Consumption on POD 0 and in PACU [ Time Frame: 12 hours ]
   Total consumption of Non-Opioid Analgesics on POD 0 and in the PACU.
10. Total Antiemetic consumption on POD 0 and in PACU [ Time Frame: 12 hours ]
    Total consumption of antiemetics on POD 0 and in PACU.
11. Presence of Nausea necessitating treatment [ Time Frame: 7 days ]
    Patient will be questioned to assess if they had nausea necessitating treatment on POD 1,2, and 7
12. Rating of Satisfaction with perioperative care [ Time Frame: 7 days ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Kristin Bevil, MD; Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03794882
• Other Study ID Numbers: 2018-0793; A530900 ( Other Identifier: UW Madison ); SMPH/ANESTHESIOLOGY/ANESTHESIO ( Other Identifier: UW Madison ); Protocol Version 8/26/2019 ( Other Identifier: UW Madison )
• First Posted: January 7, 2019
• Last Update Posted: December 21, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Wisconsin, Madison:

Hernia, Ventral; Pain, Postoperative; Opioid Use; Pain

Additional relevant MeSH terms:

Hernia; Pain, Postoperative; Hernia, Ventral; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Hernia, Abdominal