Quadratus Lumborum Block After Living Donor Kidney Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Transmuscular quadratus lumborum block
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, double-blind, randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transmuscular quadratus lumborum block group<br>Patients assigned to the Transmuscular Quadratus Lumborum (TQL) block group receive the Transmuscular Quadratus Lumborum block in a lateral decubitus position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used. | Procedure: Transmuscular quadratus lumborum block<br>* 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.<br>|
| Placebo Comparator: Control group<br>For patients assigned to the control group, 30cc of 0.9% normal saline is used for Transmuscular Quadratus Lumborum block. | Procedure: Placebo<br>* For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption for 24 postoperative hours | Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME)) | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Analgesic consumption at postoperative 6, 12, 48 hours | at postoperative 6, 12, 48 hours | 
| Resting pain numeric rating scale(NRS) | 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). | at postoperative 6, 12, 24, 48 hours | 
| Numeric rating scale of pain during movement | 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). | at postoperative 6, 12, 24, 48 hours | 
| Time to first rescue analgesics | Time to first rescue analgesics | within post-operative 24 hours | 
| Numeric rating scale at post anesthetic care unit (PACU) | 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). | 30 minutes after the end of operation | 
| Rescue analgesics administration | Rescue analgesics administration count | within post-operative 48 hours | 
| The incidence of post-operative nausea and vomiting | The incidence of post-operative nausea and vomiting | within post-operative 48 hours | 
| Patient satisfaction with pain control | Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction. | At post-operative 48 hours | 
| Pattern of injectate spread on ultrasonography | Pattern of injectate spread on ultrasonography | During procedure quadratus lumborum (QL) block | 
| Sensory blockade | 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. | 30 minutes after the end of operation | 
| Quality of Recovery Questionnaire (15-item Quality of Recovery) | 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. | At post-operative 48 hours | 
| The severity of post-operative nausea and vomiting | 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. | within post-operative 48 hours |