Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Tennessee Graduate School of Medicine
About this 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.
The following information will be collected from you or your medical record:
1. Pain medications given to you during surgery. 2. Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency. 3. Pain levels during the first 24 hours after surgery. 4. Your total hospital length of stay after surgery. 5. Any complications that you may have experienced after surgery. 6. Demographic information, medical history as well as details about your hernia repair surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Quadratus Lumborum (QL) Block
Procedure/SurgeryThe 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.
Placebo
Procedure/SurgeryThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: Quadratus Lumborum BlockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary 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).
Time frame
From the time of treatment through hospitalization completion, an average of 4 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: