Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative
Conditions
Keywords
bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain
Brief summary
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
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.
Interventions
PROCEDUREQLB
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients are randomized and allocated in blocks of ten to either epidural of QLB group
Intervention model description
Prospective randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opiate consumption | 24 hours | intravenous patient controlled analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting | 72 hours | numerical rating scale and amount of vomites |
| mobilisation | 72 hours after surgery | standing up and mobilizing |
| pain score | 7 days | numerical rating scale |
| persistent pain | 12 months | paindetect McGill |
| functional query | 12 months | assessment how pain in operation region limits daily functions |
| quality of life | 12 months | SF 36 |
Countries
Finland
Outcome results
None listed