Clinical trial NCT03496610: Surgeon Infiltration QL Block Comparison
Official title: Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quadratus Lumborum Block
Surgical Wound Infiltration
Keywords: Bupivacaine
Living donor nephrectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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

Primary outcomes:
measure: Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Self-reported Numeric Pain Scores on Postoperative Day Seven
timeFrame: Postoperative day 7
measure: Worst Bloating Severity in the First Postoperative Week
timeFrame: First seven days postoperatively
measure: Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
timeFrame: First seven days postoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Hector Martinez-Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: