Surgeon Infiltration QL Block Comparison

NCT ID: NCT03496610

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-02-23

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.

Conditions

Quadratus Lumborum Block; Surgical Wound Infiltration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Quadratus Lumborum (QL) Block

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

Group Type: ACTIVE_COMPARATOR

QL Block

Intervention Type: PROCEDURE

Patient will receive ultrasound guided QL Block

Surgical wound infiltration

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

Group Type: ACTIVE_COMPARATOR

Liposomal Bupivicaine

Intervention Type: DRUG

Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound

Interventions

Liposomal Bupivicaine

Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound

Intervention Type: DRUG

QL Block

Patient will receive ultrasound guided QL Block

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hector Martinez-Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00087144

Identifier Type: -

Identifier Source: org_study_id