An interventional study of Quadratus Lumborum (QL) Block and Placebo in Hernia, Ventral and Pain Management, sponsored by University of Tennessee Graduate School of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by University of Tennessee Graduate School of Medicine · Not applicable, Interventional, and Treatment
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:
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 70 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →University of Tennessee Graduate School of Medicine is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected.
Procedure: Placebo
The Quadratus Lumborum block will be randomly administered to half of the study patients.
Procedure: Quadratus Lumborum (QL) Block
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.
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.
Post-operative Opioid Utilization
Quantity of Post-Operative Opioid Consumption as Measured by Morphine Milliequivalents for 24 Hours After Surgery
Time frame: From the time of treatment until 24 hours after surgery
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).
Time frame: From the time of treatment through hospitalization completion, an average of 4 days.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Tennessee Graduate School of Medicine