Phase 4
N=44
Surgeon Infiltration QL Block Comparison
Quadratus Lumborum Block · Surgical Wound Infiltration
Bottom Line
View on ClinicalTrials.gov: NCT03496610 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) — 17.50; 21.25 oral morphine equivalents in milligrams — p=0.81
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal Bupivicaine (Drug); QL Block (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) |
17.50; 21.25 | 0.81 |
| SECONDARY Self-reported Numeric Pain Scores on Postoperative Day Seven |
2; 1 | 0.40 |
| SECONDARY Worst Bloating Severity in the First Postoperative Week |
4; 4 | 0.74 |
| SECONDARY Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week |
10; 12 | 0.38 |
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
Data sourced from ClinicalTrials.gov (NCT03496610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.