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

Primary Purpose

Pain, Postoperative, Opioid Use

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quadratus Lumborum Block
Standard Medical Management
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QLB + Medical Management

Standard Medical Management

Arm Description

Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.

Subjects will receive Intervention: Procedure: Standard Medical Management as needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
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 in PACU
Duration of patients' time in PACU.
Postoperative Time to Discharge
Total postoperative time until discharge.
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.
Number of Participants Who Report Nausea in PACU
Patient will be questioned to assess if they have nausea in PACU.
Total Antiemetic Consumption on POD 0 and in PACU
Total consumption of antiemetics on POD 0 and in PACU.
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
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.
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Total consumption of Non-Opioid Analgesics in the PACU.
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.
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.

Full Information

First Posted
December 20, 2018
Last Updated
August 24, 2022
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03794882
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
administrative challenges and complications due to the COVID-19 pandemic
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use
Keywords
Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
The participant is blinded to the treatment.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QLB + Medical Management
Arm Type
Experimental
Arm Description
Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.
Arm Title
Standard Medical Management
Arm Type
Active Comparator
Arm Description
Subjects will receive Intervention: Procedure: Standard Medical Management as needed.
Intervention Type
Combination Product
Intervention Name(s)
Quadratus Lumborum Block
Other Intervention Name(s)
QLB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Medical Management
Intervention Description
Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Primary Outcome Measure Information:
Title
Postoperative Day (POD) 1 Pain Score
Description
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
Secondary Outcome Measure Information:
Title
Pain Score at Rest
Description
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
Title
Pain Score With Activity
Description
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
Title
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
Description
Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
Time Frame
PACU, POD1, POD2, POD7
Title
Location of Most Severe Pain
Description
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
Title
Time in PACU
Description
Duration of patients' time in PACU.
Time Frame
48 hours
Title
Postoperative Time to Discharge
Description
Total postoperative time until discharge.
Time Frame
72 hours
Title
Numbness Distribution in PACU
Description
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
Title
Number of Participants Who Report Nausea in PACU
Description
Patient will be questioned to assess if they have nausea in PACU.
Time Frame
12 hours
Title
Total Antiemetic Consumption on POD 0 and in PACU
Description
Total consumption of antiemetics on POD 0 and in PACU.
Time Frame
12 hours
Title
Number of Participants With Presence of Nausea Necessitating Treatment
Description
Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7
Time Frame
POD1, POD2, POD7
Title
Rating of Satisfaction With Perioperative Care
Description
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
Title
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Description
Total consumption of Non-Opioid Analgesics in the PACU.
Time Frame
12 hours
Title
Additional Analgesics in Milliliters Administered in the Operating Room
Description
This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.
Time Frame
6 hours
Title
Additional Analgesics in Milligrams Administered in the Operating Room
Description
This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject is scheduled for elective laparoscopic ventral hernia repair; The subject is ≥ 18 years and ≤ 80 years; The patient agrees to receive a quadratus lumborum block American Society of Anesthesiologists class 1-3. Exclusion Criteria: Subject is < 18 years of age or >80 years of age; Subject is non-English speaking; Subject is known or believed to be pregnant; Subject is a prisoner; Subject has impaired decision-making capacity per discretion of the Investigator; Significant renal, cardiac or hepatic disease per discretion of the investigator; American Society of Anesthesiologists class 4-5; Known hypersensitivity and/or allergies to local anesthetics; Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point in their lives). Repair of a recurrent ventral hernia Repair of multiple ventral hernias Unobtainable sonographic views Lacking health insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Bevil, MD
Organizational Affiliation
Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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