Skip to main content
OpenTrials
Completed

NCT Number: NCT04908761

Quadratus Lumborum Block After Living Donor Kidney Transplantation

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital

Exclusion criteria

  • Patients with severe pain before surgery
  • Patients with a history hypersensitivity reactions on fentanyl or ropivacaine
  • Patients who cannot maintain patient-controlled analgesia (PCA) by themselves

④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied

⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial

Treatment and study plan

Transmuscular quadratus lumborum block

Procedure

Patients assigned to the TQL block group receive the TQL block in a supine position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.

Placebo

Procedure

For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.

Primary outcomes

  1. Analgesic consumption for 24 postoperative hours

    Time frame: 24 hours postoperatively

    Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))

Secondary outcomes

  1. Analgesic consumption

    Time frame: at postoperative 6, 12, 48 hours

    Analgesic consumption at postoperative 6, 12, 48 hours

  2. Resting pain numeric rating scale(NRS)

    Time frame: at postoperative 6, 12, 24, 48 hours

    Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48 hours. Numeric rating scare is 11-point scale from 0 to 10, The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

  3. Numeric rating scale of pain during movement

    Time frame: at postoperative 6, 12, 24, 48 hours

    Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48 hours Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

  4. Time to first rescue analgesics

    Time frame: within post-operative 24 hours

    Time to first rescue analgesics

  5. Numeric rating scale at post anesthetic care unit (PACU)

    Time frame: 30 minutes after the end of operation

    Numeric rating scale at post anesthetic care unit Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

  6. Rescue analgesics administration

    Time frame: within post-operative 48 hours

    Rescue analgesics administration count

  7. The incidence of post-operative nausea and vomiting

    Time frame: within post-operative 48 hours

    The incidence of post-operative nausea and vomiting

  8. Patient satisfaction with pain control

    Time frame: At post-operative 48 hours

    Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction.

  9. Pattern of injectate spread on ultrasonography

    Time frame: During procedure quadratus lumborum (QL) block

    Pattern of injectate spread on ultrasonography

  10. Sensory blockade

    Time frame: 30 minutes after the end of operation

    After surgery, an alcohol swab is used to evaluate the loss of cold sensation. It is evaluated by dividing into nine regions bordering the rib margin on the side of the surgery, the horizontal line passing through the umbilicus and pubis, and the vertical line of the midclavicular line, anterior axillary line, and mid axillary line. If cold sensation is the same as the opposite part of the regions, marked as 2 points, if decreased marked as 1 point, and if not sensed at all, marked as 0 point.

  11. Quality of Recovery Questionnaire (15-item Quality of Recovery)

    Time frame: At post-operative 48 hours

    Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

  12. The severity of post-operative nausea and vomiting

    Time frame: within post-operative 48 hours

    The severity of post-operative nausea and vomiting, The severity of the nausea and vomitting is asked to patient and expressed as none, mild, or severe.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Dec 27, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.