Clinical trial

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

Name
Pro00087144
Description
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.
Trial arms
Trial start
2021-01-25
Estimated PCD
2023-02-23
Trial end
2023-02-23
Status
Completed
Phase
Early phase I
Treatment
Liposomal Bupivicaine
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
Arms:
Surgical wound infiltration
QL Block
Patient will receive ultrasound guided QL Block
Arms:
Quadratus Lumborum (QL) Block
Size
44
Primary endpoint
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
24 hours postoperatively
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2024-03-05

1 organization

1 product

2 indications

Organization
Duke University