Surgeon Infiltration QL Block Comparison

Duke University

Status and phase: Completed; Phase 4

Conditions: Quadratus Lumborum Block; Surgical Wound Infiltration

Treatments: Procedure: QL Block; Drug: Liposomal Bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03496610

Pro00087144

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Quadratus Lumborum (QL) Block

Active Comparator group

Description:

Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.

Treatment:

Procedure: QL Block

Surgical wound infiltration

Active Comparator group

Description:

Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.

Treatment:

Drug: Liposomal Bupivicaine