QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Study Overview
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Brief Summary
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There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic. Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain. Recently quadratus lumborum block (QLB) has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. A single shot QLB has reported to last up to 48 hours. Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known. 90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.

Official Title
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Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy

Conditions
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Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone sodium phosphate
* Drug: Ropivacaine Hydrocloride
* Drug: Sodium Chloride 9mg/mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with renal cancer coming to the laparoscopic radical nephrectomy Exclusion Criteria: age under 18y or over 85y diabetes type 1 with complications no co-operation or inadequate finnish language skills persistent pain for other reason severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated for other reason any type of steroid in regular use oxycodone contraindicated medications changing notably paracetamol (acetaminophen) and/or ropivacaine metabolism in regular use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: QLB with dexamethasone<br>Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml | Drug: Dexamethasone sodium phosphate<br>* Dexamethasone injection<br>* Other names: Oradexon;Drug: Ropivacaine Hydrocloride<br>* Ropivacaine injection<br>|
| Active Comparator: QLB without dexamethasone<br>Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml | Drug: Ropivacaine Hydrocloride<br>* Ropivacaine injection<br>Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|
| Placebo Comparator: Placebo<br>Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml | Drug: Sodium Chloride 9mg/mL<br>* Sodium Chloride injection<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opiate consumption | cumulative opiate consumption postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opiate consumption | cumulative opiate consumption postoperatively | 72 hours | 
| postoperative nausea | numerical rating scale | 72 hours | 
| pain score | numerical rating scale | 7 days | 
| mobilization | time to standing up and mobilizing after surgery | 72 hours | 
| quality of life | SF36 query | 12 months | 
| persistent pain | paindetect McGill | 12 months | 
| functional query | assessment how pain in operation region limits daily functions | 12 months | 
| postoperative vomiting | amount of vomites | 72 hours |