Surgeon Infiltration QL Block Comparison

Quadratus Lumborum Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496610
• Other study ID #: Pro00087144
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Quadratus Lumborum Block
• Surgical Wound
• Surgical Wound Infiltration

Intervention

Drug:
• Liposomal Bupivicaine
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound

Procedure:
• QL Block
Patient will receive ultrasound guided QL Block

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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