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Completed

NCT Number: NCT03496610

Surgeon Infiltration QL Block Comparison

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.

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Key information

Conditions

Quadratus Lumborum Block Surgical Wound Infiltration

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal Bupivicaine

Drug

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

QL block

Procedure

Patient will receive ultrasound guided QL Block

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)

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Self-reported Numeric Pain Scores on Postoperative Day Seven

    Time frame: Postoperative day 7

    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.

  2. Worst Bloating Severity in the First Postoperative Week

    Time frame: First seven days postoperatively

    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.

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

    Time frame: First seven days postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2018
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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