Surgeon Infiltration QL Block Comparison

Study Overview
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Brief Summary
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The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a nerve block) that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.

Official Title
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Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients

Conditions
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Quadratus Lumborum Block, Surgical Wound Infiltration

Intervention / Treatment
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* Drug: Liposomal Bupivicaine
* Procedure: QL Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking ASA 1-2 patients undergoing living donor nephrectomy Exclusion Criteria: ASA 3 or 5 Diagnosis of chronic pain Daily chronic opioid use (over 3 months of continuous opioid use) Inability to communicate pain scores or need for analgesia Infection at the site of block placement Pregnant women (as determined by standard of care day-of surgery urine bHCG) Intolerance/allergy to local anesthetics Weight <50 kg Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum (QL) Block<br>Patients will receive a bilateral ultrasound guided QL block by the anesthesia team. | Procedure: QL Block<br>* Patient will receive ultrasound guided QL Block<br>|
| Active Comparator: Surgical wound infiltration<br>Patients will receive 166 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon. | Drug: Liposomal Bupivicaine<br>* Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain scores as measured by the NRS 11 |  | Up to 7 days | 
| Percentage of GI Complications |  | Up to 7 days | 
| Physical activity after surgery as measured by walking test |  | Up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Living donor nephrectomy