QLB and Radical Cystectomy, Postoperative Pain (BladderQLB)
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|ClinicalTrials.gov Identifier: NCT03328988|
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : December 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Chronic Pain Post-Proceduraal Nausea and Vomiting, Postoperative||Procedure: QLB||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized controlled study|
|Masking:||None (Open Label)|
|Masking Description:||Patients are randomized and allocated in blocks of ten to either epidural of QLB group|
|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|
|Actual Study Start Date :||April 27, 2017|
|Estimated Primary Completion Date :||April 27, 2020|
|Estimated Study Completion Date :||April 27, 2020|
Experimental: Quadratus lumborum block
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.
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Other Name: quadratus lumborum block
No Intervention: Epidural
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
- opiate consumption [ Time Frame: 24 hours ]intravenous patient controlled analgesia
- pain score [ Time Frame: 7 days ]numerical rating scale
- postoperative nausea and vomiting [ Time Frame: 72 hours ]numerical rating scale and amount of vomites
- mobilisation [ Time Frame: 72 hours after surgery ]standing up and mobilizing
- quality of life [ Time Frame: 12 months ]SF 36
- persistent pain [ Time Frame: 12 months ]paindetect McGill
- functional query [ Time Frame: 12 months ]assessment how pain in operation region limits daily functions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328988
|Contact: Maija-Liisa Kalliomaki, PhDfirstname.lastname@example.org|
|Contact: Andrus Korgvee, MDemail@example.com|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, 33521|
|Contact: Maija-Liisa Kalliomaki, PhD +358331169424 firstname.lastname@example.org|
|Contact: Eija Junttila, PhD +358331166001 email@example.com|
|Study Director:||Maija-Liisa Kalliomaki, PhD||Tampere University Hospital, Department of anesthesia|