Surgeon Infiltration QL Block Comparison

NCT03496610 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00087144
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Bupivacaine; Living donor nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self-reported Numeric Pain Scores on Postoperative Day Seven

  Postoperative day 7

• Worst Bloating Severity in the First Postoperative Week

  First seven days postoperatively

• Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week

  First seven days postoperatively

Study Arms (2)

Quadratus Lumborum (QL) Block

ACTIVE COMPARATOR

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

Procedure: QL Block

Surgical wound infiltration

ACTIVE COMPARATOR

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

Interventions

Liposomal Bupivicaine DRUG

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

Surgical wound infiltration

QL Block PROCEDURE

Patient will receive ultrasound guided QL Block

Quadratus Lumborum (QL) Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• ASA 1-2 patients undergoing living donor nephrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Results Point of Contact

• Title: Hector F. Martinez-Wilson, MD, PhD
• Organization: Duke University

hector.martinez-wilson@duke.edu

919-681-6437

Study Officials

• Hector Martinez-Wilson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: January 25, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)