Clinical trial NCT03328988: QLB and Radical Cystectomy, Postoperative Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Chronic Pain Post-Proceduraal
Nausea and Vomiting, Postoperative
Keywords: bladder cancer
radical cystectomy
epidural analgesia
quadratus lumborum block
postoperative pain
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: opiate consumption
timeFrame: 24 hours
Secondary outcomes:
measure: pain score
timeFrame: 7 days
measure: postoperative nausea and vomiting
timeFrame: 72 hours
measure: mobilisation
timeFrame: 72 hours after surgery
measure: quality of life
timeFrame: 12 months
measure: persistent pain
timeFrame: 12 months
measure: functional query
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Department of anesthesia
name: Maija-Liisa Kalliomaki, PhD
role: STUDY_DIRECTOR
References:
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