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Surgeon Infiltration QL Block Comparison

Primary Purpose

Quadratus Lumborum Block, Surgical Wound Infiltration

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liposomal Bupivicaine

QL Block

About this trial

This is an interventional supportive care trial for Quadratus Lumborum Block focused on measuring Bupivacaine, Living donor nephrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Quadratus Lumborum (QL) Block

Surgical wound infiltration

Arm Description

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

Patients will receive 166 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.

Outcomes

Primary Outcome Measures

Opioid consumption

Secondary Outcome Measures

Numeric pain scores as measured by the NRS 11

Percentage of GI Complications

Physical activity after surgery as measured by walking test

Full Information

NCT ID

NCT03496610

First Posted

April 5, 2018

Last Updated

March 15, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03496610

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 25, 2021 (Actual)

Primary Completion Date

February 23, 2023 (Actual)

Study Completion Date

February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Quadratus Lumborum Block, Surgical Wound Infiltration

Keywords

Bupivacaine, Living donor nephrectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quadratus Lumborum (QL) Block

Arm Type

Active Comparator

Arm Description

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

Arm Title

Surgical wound infiltration

Arm Type

Active Comparator

Arm Description

Patients will receive 166 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.

Intervention Type

Drug

Intervention Name(s)

Liposomal Bupivicaine

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

QL Block

Intervention Description

Patient will receive ultrasound guided QL Block

Primary Outcome Measure Information:

Title

Opioid consumption

Time Frame

Up to 7 days

Secondary Outcome Measure Information:

Title

Numeric pain scores as measured by the NRS 11

Time Frame

Up to 7 days

Title

Percentage of GI Complications

Time Frame

Up to 7 days

Title

Physical activity after surgery as measured by walking test

Time Frame

Up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hector Martinez-Wilson, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Surgeon Infiltration QL Block Comparison

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