Pain, PostoperativePhase 4NCT03794882
Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair
A Phase 4 study testing Quadratus Lumborum Block and Standard Medical Management in people with Pain, Postoperative and Opioid Use, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Quadratus Lumborum Block and Standard Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 12 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair
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.
Read the 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.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Quadratus Lumborum Block, Standard Medical Management
- Keywords
- Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain
- Medical subject headings
- Pain, Postoperative, Hernia, Ventral, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum BlockCombination product
Also called QLB
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 ManagementProcedure or surgery
Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| QLB + Medical Management | Experimental | Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. Receives: Combination Product: Quadratus Lumborum Block; Procedure: Standard Medical Management |
| Standard Medical Management | Active comparator | Subjects will receive Intervention: Procedure: Standard Medical Management as needed. Receives: Procedure: Standard Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (14)
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.
Measured: PACU, POD1, POD2, POD7
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.
Measured: PACU, POD1, POD2, POD7
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
Measured: PACU, POD1, POD2, POD7
Location of Most Severe Pain
Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.
Measured: PACU, POD1, POD2, POD7
Time in PACU
Duration of patients' time in PACU.
Measured: 48 hours
Postoperative Time to Discharge
Total postoperative time until discharge.
Measured: 72 hours
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.
Measured: 12 hours
Number of Participants Who Report Nausea in PACU
Patient will be questioned to assess if they have nausea in PACU.
Measured: 12 hours
Total Antiemetic Consumption on POD 0 and in PACU
Total consumption of antiemetics on POD 0 and in PACU.
Measured: 12 hours
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
Measured: POD1, POD2, POD7
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.
Measured: POD1, POD2, POD7
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Total consumption of Non-Opioid Analgesics in the PACU.
Measured: 12 hours
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.
Measured: 6 hours
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start6 May 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: administrative challenges and complications due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Bevil, MD, Principal investigator, Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794882
- Sponsor's protocol ID
- 2018-0793
- Other IDs
- A530900, SMPH/ANESTHESIOLOGY/ANESTHESIO, Protocol Version 8/26/2019
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2018
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT03794882
- Acronym / sponsor ID
- 2018-0793
- Conditions
- Pain, Postoperative, Opioid Use
- Keywords
- Hernia, Ventral, Pain, Postoperative, Opioid Use, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: administrative challenges and complications due to the COVID-19 pandemic
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| QLB + Medical Management | Experimental | Combination Product: Quadratus Lumborum Block, Procedure: Standard Medical ManagementSubjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed. |
| Standard Medical Management | Active comparator | Procedure: Standard Medical ManagementSubjects will receive Intervention: Procedure: Standard Medical Management as needed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus Lumborum BlockAlso: QLB30 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. | Combination product | QLB + Medical Management |
| Standard Medical ManagementStandard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone | Procedure or surgery | QLB + Medical Management, Standard Medical Management |
Primary outcome
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.
14 secondary outcomes
Pain Score at Rest
Time frame: PACU, POD1, POD2, POD7
Pain Score With Activity
Time frame: PACU, POD1, POD2, POD7
Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
Time frame: PACU, POD1, POD2, POD7
Location of Most Severe Pain
Time frame: PACU, POD1, POD2, POD7
Time in PACU
Time frame: 48 hours
Postoperative Time to Discharge
Time frame: 72 hours
Numbness Distribution in PACU
Time frame: 12 hours
Number of Participants Who Report Nausea in PACU
Time frame: 12 hours
Total Antiemetic Consumption on POD 0 and in PACU
Time frame: 12 hours
Number of Participants With Presence of Nausea Necessitating Treatment
Time frame: POD1, POD2, POD7
Rating of Satisfaction With Perioperative Care
Time frame: POD1, POD2, POD7
Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
Time frame: 12 hours
Additional Analgesics in Milliliters Administered in the Operating Room
Time frame: 6 hours
Additional Analgesics in Milligrams Administered in the Operating Room
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Bevil, MD principal investigator
Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadratus Lumborum Block and Standard Medical Management in people with Pain, Postoperative and Opioid Use, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Day (POD) 1 Pain Score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.