Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime. We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block. The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.

Detailed Description
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Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids. The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours. The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.

Official Title
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Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Percutaneous Nephrolithotomy

Conditions
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Kidney Stone

Intervention / Treatment
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* Procedure: Ropivacaine TQL block
* Procedure: Saline TQL block
* Drug: Ropivacaine
* Drug: Saline
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil. Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3 Exclusion Criteria: Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy -

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine TQL block<br>Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75% | Procedure: Ropivacaine TQL block<br>* Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure<br>* Other names: Naropin;Drug: Ropivacaine<br> <br> Device: Ultrasound<br> <br> |
| Placebo Comparator: Placebo TQL block<br>Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9% | Procedure: Saline TQL block<br>* Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure<br>Drug: Saline<br> <br> Device: Ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record | 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Data from PCA pump and patient electronic file | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | 
| Pain score at rest (NRS 0-10/10) | Pain score NRS | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | 
| Pain score at sitting position (NRS 0-10/10) | Pain score NRS | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | 
| Time to first ambulation - get out of bed | Time to first ambulation from bed to walk on the floor | 0-24 hours postoperatively | 
| Opioid side effects (nausea, vomiting) | PONV, number of episodes, antiemetics | 0-24 hours postoperatively | 
| NRS score during application of the TQL block (NRS 0-10/10) | Procedure discomfort | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Transmuscular quadratus lumborum block, Block, Ropivacaine, TQL, percutaneous nephrolithotomy, PNL, Ultrasound-guided