QLB and Radical Cystectomy, Postoperative Pain

Study Overview
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Brief Summary
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There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block 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. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours. Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain. 44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Detailed Description
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44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Official Title
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Comparing Two Different Analgesic Block Methods for Postoperative Pain and Recovery After Surgery -Quadratus Lumborum Block (QLB): the Effect on Peri- and Postoperative Pain and Recovery After Radical Cystectomy

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

Intervention / Treatment
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* Procedure: QLB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with bladder cancer coming to the open radical cystectomy. Exclusion Criteria: age under 18y or over 85y, diabetes type 1 with complications, no co-operation or inadequate finnish language, persistent pain for other reason.

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
Interventional Model Description: Prospective randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus lumborum block<br>Single shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group. | Procedure: QLB<br>* bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle<br>* Other names: quadratus lumborum block;|
| No Intervention: Epidural<br>Epidural catheter (placed before anesthesia induction), ropivacaine 75 mg in 50 mL isotonic saline (1,5 mg/mL), induction bolus after surgery 1 mL/10 kg ideal weight and there on continuous infusion 2-8 mL/h according to analgesic need. 22 patients will be allocated in this group. This is the current standard for postoperative pain relief in cystectomy patients in our hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opiate consumption | intravenous patient controlled analgesia | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | numerical rating scale | 7 days | 
| postoperative nausea and vomiting | numerical rating scale and amount of vomites | 72 hours | 
| mobilisation | standing up and mobilizing | 72 hours after surgery | 
| quality of life | SF 36 | 12 months | 
| persistent pain | paindetect McGill | 12 months | 
| functional query | assessment how pain in operation region limits daily functions | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain