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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03794882
• Other study ID #: 2018-0793
• Secondary ID: A530900SMPH/ANES
• Status: Terminated
• Phase: Phase 4
• Start date: May 6, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: August 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Opioid Use
• Pain, Postoperative

Intervention

Combination Product:
• Quadratus 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.

Procedure:
• Standard Medical Management
Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours
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.	PACU, POD1, POD2, POD7
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.	PACU, POD1, POD2, POD7
Secondary	Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)	Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.	PACU, POD1, POD2, POD7
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.	PACU, POD1, POD2, POD7
Secondary	Time in PACU	Duration of patients' time in PACU.	48 hours
Secondary	Postoperative Time to Discharge	Total postoperative time until discharge.	72 hours
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.	12 hours
Secondary	Number of Participants Who Report Nausea in PACU	Patient will be questioned to assess if they have nausea in PACU.	12 hours
Secondary	Total Antiemetic Consumption on POD 0 and in PACU	Total consumption of antiemetics on POD 0 and in PACU.	12 hours
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	POD1, POD2, POD7
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.	POD1, POD2, POD7
Secondary	Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams	Total consumption of Non-Opioid Analgesics in the PACU.	12 hours
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.	6 hours
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.	6 hours