Hernia, VentralVHRNCT06953635
Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair
A study testing Quadratus Lumborum (QL) Block in people with Hernia, Ventral and Pain Management, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Pain Management
- What is being tested?
- Quadratus Lumborum (QL) Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Able to read and understand study procedures
- Willing to participate and sign an informed consent form
- Open approaches to ventral hernia repair
- Clean (CDC Class I), clean-contaminated (CDC Class II)
- Elective surgery
- Mesh placed in the retromuscular position
Who cannot join
- Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- Patient has a contraindication to receiving the drug and/or procedure: allergy/sensitivity to the drug, coagulopathy, abdominal wall infection at the drug administration site, systemic infection, anatomical distortion, neuropathy
- Emergent procedure
- Mesh not placed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Trey A Henderson, MD, 865-305-7540, thenderson@utmck.edu
Elizabeth A LaFontaine, BS, MBSCR, CNC, 865-305-9662, ealafontaine@utmck.edu
About this study
Official title: Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial
The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.
Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.
Read more
The following information will be collected from you or your medical record:
- Pain medications given to you during surgery.
- Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
- Pain levels during the first 24 hours after surgery.
- Your total hospital length of stay after surgery.
- Any complications that you may have experienced after surgery.
- Demographic information, medical history as well as details about your hernia repair surgery.
Read the detailed description
Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.
- Conditions
- Hernia, Ventral, Pain Management
- Being tested
- Quadratus Lumborum (QL) Block, Placebo
- Keywords
- Regional Anesthesia, Postoperative Pain, Ventral Hernia Repair
- Medical subject headings
- Hernia, Ventral, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum (QL) BlockProcedure or surgery
The intervention arm will receive bilateral quadratus lumborum blocks in the preoperative holding area prior to surgery. The syringe will contain a total of 60 mL of 0.25% Ropivacaine with 4 mg of Decadron. The anesthesiology pain team provider will administer 30 mL on the left side and 30 mL on the right side of the abdominal wall. The patient will receive one injection site per flank. During the procedure, the patient is placed in the left and then right lateral decubitus position and the ultrasound probe is placed above the iliac crest at the mid axillary line. The pain team provider will move the probe posteriorly to identify the "shamrock sign." Under ultrasound guidance, a needle is inserted in an in- plane approach through the quadratus lumborum (QL) muscle until reaching the middle of the thoracolumbar fascia layer between QL and psoas muscle. After negative aspiration for blood, injection will allow the spread of local anesthetic between the QL and psoas muscle on each side.
PlaceboProcedure or surgery
The placebo control group will receive the same quadratus lumborum (QL) block procedure as the intervention group, with the only difference being the injection of 60 mL of saline instead of local anesthetic. The anesthesiology team will administer 30 mL on each side of the abdominal wall, with one injection site per flank. The patient will be positioned in the left and right lateral decubitus positions, and the ultrasound probe will be placed above the iliac crest at the mid-axillary line to identify the "shamrock sign." The needle will be inserted through the QL muscle to the thoracolumbar fascia layer, between the QL and psoas muscle. After negative aspiration for blood, saline will be injected, allowing spread between the QL and psoas muscle on each side.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected. Receives: Procedure: Placebo |
| Quadratus Lumborum Block | Experimental | The Quadratus Lumborum block will be randomly administered to half of the study patients. Receives: Procedure: Quadratus Lumborum (QL) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Opioid Utilization
Quantity of Post-Operative Opioid Consumption as Measured by Morphine Milliequivalents for 24 Hours After Surgery
Measured: From the time of treatment until 24 hours after surgery
Secondary outcomes (1)
Numerical rating Pain Score
Patient-reported pain will be recorded by the nursing staff at a minimum once per day, every day from the time of surgery until the patient is discharged from the hospital, an average of 4 days.
Patient-reported pain will be scored on the validated Numeric Rating Scale (NRS), where patients are asked to choose a number between 0 and 10 that best describes their level of pain with "0" meaning "no pain" (better outcome) and "10" meaning "worst pain imaginable" (worse outcome).
Measured: From the time of treatment through hospitalization completion, an average of 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion28 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design This is a prospective, double-blinded, randomized, placebo-controlled clinical trial comparing QL blocks to placebo for pain control for patients undergoing open VHR.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaela E Blake, MD, Principal investigator, The University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953635
- Sponsor's protocol ID
- 5342
- Acronym
- VHR
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy A, Bhoi D, Chhabra A, Mohan VK, Darlong V, Prasad G. Quadratus lumborum block vs. transversus abdominis plane block in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia in adults: A randomised controlled trial. Indian J Anaesth. 2023 Feb;67(2):207-215. doi: 10.4103/ija.ija_304_22. Epub 2023 Feb 16.
PubMed 37091451Liu X, Song T, Chen X, Zhang J, Shan C, Chang L, Xu H. Quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal surgeries: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Mar 2;20(1):53. doi: 10.1186/s12871-020-00967-2.
PubMed 32122319Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.
PubMed 35717988Schlosser KA, Renshaw SM, Tamer RM, Strassels SA, Poulose BK. Ventral hernia repair: an increasing burden affecting abdominal core health. Hernia. 2023 Apr;27(2):415-421. doi: 10.1007/s10029-022-02707-6. Epub 2022 Dec 26.
PubMed 36571666
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06953635
- Acronym / sponsor ID
- VHR / 5342
- Conditions
- Hernia, Ventral, Pain Management
- Keywords
- Regional Anesthesia, Postoperative Pain, Ventral Hernia Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.
Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.
The following information will be collected from you or your medical record:
- Pain medications given to you during surgery.
- Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
- Pain levels during the first 24 hours after surgery.
- Your total hospital length of stay after surgery.
- Any complications that you may have experienced after surgery.
- Demographic information, medical history as well as details about your hernia repair surgery.
Detailed description
Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study Design This is a prospective, double-blinded, randomized, placebo-controlled clinical trial comparing QL blocks to placebo for pain control for patients undergoing open VHR.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: PlaceboThe control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected. |
| Quadratus Lumborum Block | Experimental | Procedure: Quadratus Lumborum (QL) BlockThe Quadratus Lumborum block will be randomly administered to half of the study patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >18 years of age
- Able to read and understand study procedures
- Willing to participate and sign an informed consent form
- Open approaches to ventral hernia repair
- Clean (CDC Class I), clean-contaminated (CDC Class II)
Key exclusion criteria (4 listed)
- Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- Patient has a contraindication to receiving the drug and/or procedure: allergy/sensitivity to the drug, coagulopathy, abdominal wall infection at the drug administration site, systemic infection, anatomical distortion, neuropathy
- Emergent procedure
- Mesh not placed
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 (QL) BlockThe intervention arm will receive bilateral quadratus lumborum blocks in the preoperative holding area prior to surgery. The syringe will contain a total of 60 mL of 0.25% Ropivacaine with 4 mg of Decadron. The anesthesiology pain team provider will administer 30 mL on the left side and 30 mL on the right side of the abdominal wall. The patient will receive one injection site per flank. During the procedure, the patient is placed in the left and then right lateral decubitus position and the ultrasound probe is placed above the iliac crest at the mid axillary line. The pain team provider will move the probe posteriorly to identify the "shamrock sign." Under ultrasound guidance, a needle is inserted in an in- plane approach through the quadratus lumborum (QL) muscle until reaching the middle of the thoracolumbar fascia layer between QL and psoas muscle. After negative aspiration for blood, injection will allow the spread of local anesthetic between the QL and psoas muscle on each side. | Procedure or surgery | Quadratus Lumborum Block |
| PlaceboThe placebo control group will receive the same quadratus lumborum (QL) block procedure as the intervention group, with the only difference being the injection of 60 mL of saline instead of local anesthetic. The anesthesiology team will administer 30 mL on each side of the abdominal wall, with one injection site per flank. The patient will be positioned in the left and right lateral decubitus positions, and the ultrasound probe will be placed above the iliac crest at the mid-axillary line to identify the "shamrock sign." The needle will be inserted through the QL muscle to the thoracolumbar fascia layer, between the QL and psoas muscle. After negative aspiration for blood, saline will be injected, allowing spread between the QL and psoas muscle on each side. | Procedure or surgery | Control |
Primary outcome
Post-operative Opioid Utilization
Time frame: From the time of treatment until 24 hours after surgery
Quantity of Post-Operative Opioid Consumption as Measured by Morphine Milliequivalents for 24 Hours After Surgery
1 secondary outcome
Numerical rating Pain Score
Time frame: From the time of treatment through hospitalization completion, an average of 4 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Results publication: PubMed 37091451Roy A, Bhoi D, Chhabra A, Mohan VK, Darlong V, Prasad G. Quadratus lumborum block vs. transversus abdominis plane block in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia in adults: A randomised controlled trial. Indian J Anaesth. 2023 Feb;67(2):207-215. doi: 10.4103/ija.ija_304_22. Epub 2023 Feb 16.
- Results publication: PubMed 32122319Liu X, Song T, Chen X, Zhang J, Shan C, Chang L, Xu H. Quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing abdominal surgeries: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Mar 2;20(1):53. doi: 10.1186/s12871-020-00967-2.
- Results publication: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Results publication: PubMed 35717988Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.
- Results publication: PubMed 36571666Schlosser KA, Renshaw SM, Tamer RM, Strassels SA, Poulose BK. Ventral hernia repair: an increasing burden affecting abdominal core health. Hernia. 2023 Apr;27(2):415-421. doi: 10.1007/s10029-022-02707-6. Epub 2022 Dec 26.
- Individual participant dataSharing planned: No
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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.
Kaela E Blake, MD principal investigator
The University of Tennessee Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum (QL) Block in people with Hernia, Ventral and Pain Management, run by University of Tennessee Graduate School of Medicine 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 May 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaela E Blake, MD (865-305-9620, kblake@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Opioid Utilization (time frame: From the time of treatment until 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953635, which also lists 5 linked publications.
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 1 May 2025.