Surgeon Infiltration QL Block Comparison

Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients

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.

Study Overview

• Status: Completed
• Conditions: Quadratus Lumborum Block; Surgical Wound Infiltration
• Intervention / Treatment: Procedure: QL Block; Drug: Liposomal Bupivicaine

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hector Martinez-Wilson, MD; Phone Number: 617-513-3224; Email: hector.martinez-wilson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum (QL) Block; Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.	Procedure: QL Block; Patient will receive ultrasound guided QL Block
Active Comparator: 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.	Drug: Liposomal Bupivicaine; Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Numeric Pain Scores on Postoperative Day Seven	Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.	Postoperative day 7
Worst Bloating Severity in the First Postoperative Week	Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.	First seven days postoperatively
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week	Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes "without any difficulty" at any time during the first postoperative week is reported.	First seven days postoperatively

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Hector Martinez-Wilson, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Living donor nephrectomy; Bupivacaine
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Pro00087144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No