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Completed

NCT Number: NCT03110081

Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery

This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.

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Key information

Conditions

Open Nephrectomy Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.

Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults having for open unilateral partial nephrectomy surgery.

Exclusion criteria

  • Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-

Treatment and study plan

quadratus lumborum block

Procedure

Quadratus lumborum (QL) block for open partial nephrectomy.

Epidural Analgesia

Procedure

Epidural analgesia for open partial nephrectomy.

Primary outcomes

  1. Total opioid consumption

    Time frame: Arrival to post anesthesia care unit until 72 hours after surgery

    Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.

  2. Postoperative pain

    Time frame: Arrival to post anesthesia care unit until 72 hours after surgery

    Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores.

Secondary outcomes

  1. Patient Global Assessment

    Time frame: Three days after surgery

    Patient global assessment of pain control is measured on an ordinal scale by the patient. Patients can rate their pain control as poor, fair, good, or excellent.

  2. Doses of antiemetic medications administered

    Time frame: Arrival to post anesthesia care unit until the third day after surgery

    Count of the number of antiemetic medications administered.

  3. Duration of postoperative hospitalization

    Time frame: From the date of surgery to hospital discharge, assessed up to 12 months.

    Duration of postoperative hospitalization

  4. Episodes of hypotension

    Time frame: Arrival to post anesthesia care unit until the third day after surgery

    Number of episodes of hypotension during hospital stay, defined by MAP less than 65 mmHg requiring intervention.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: QL Analgesia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Apr 29, 2021

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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